Data / Medical devices / United Kingdom / Platinum Focus Group Ltd.
Platinum Focus Group Ltd.: FDA-registered device maker in London London, City of, United Kingdom, 98 510(k) clearances and 1 PMA approval
Platinum Focus Group Ltd. is registered with the FDA (registration 3030446844) in London London, City of, United Kingdom. It lists 166 device types. The FDA files 98 510(k) clearances and 1 PMA approval under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030446844
- Address
- Unit 5, 1000 North Circular Road, London London, City of, United Kingdom, NW2 7JP
- Owner or operator
- Platinum Focus Group Ltd. (10089900)
- Roles
- Contract sterilizer, Exporter to the US, Manufacturer
- First device listed
- January 19, 2024
- Registered through
- 2026
- Brand names listed
- - Endoscopic grasping/cutting instrument, non-powered, exempt, 3M Cavilon No Sting Barrier Film Spray Bottle, 510(k), ADAPTOR, URETERAL CATHETER, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE BYG - MASK, OXYGEN, Acrobat 2 Calibrated Tip Wire Guide, AirSport Ankle Brace Right Medium and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | PTI | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| March 25, 2024 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | DYB | Substantially Equivalent | Cook Medical | accessdata.fda.gov |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 16, 2022 | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | FMK | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 11, 2022 | K222744 | Sol-M Luer Lock Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| February 17, 2022 | K220137 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| May 20, 2021 | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | FCG | Substantially Equivalent | Cook Ireland, Ltd. | accessdata.fda.gov |
| May 29, 2019 | K182403 | Peel-Away Introducer | FED | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 1, 2019 | K183413 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifeciences, LLC | accessdata.fda.gov |
| May 1, 2019 | K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | CCK | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| March 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 20, 2019 | K183399 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 20, 2018 | K183036 | Dilator Sets | DRE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 24, 2018 | K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | KNS | Substantially Equivalent | Wilson-Cook Medical Inc./Cook Endoscopy | accessdata.fda.gov |
| May 3, 2018 | K172980 | Micropuncture Pedal Access Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 1, 2018 | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | FGE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 30, 2018 | K171997 | Mandril Wire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 30, 2018 | K171988 | Performer Guiding Sheath | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 9, 2018 | K171764 | Fixed Core Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 20, 2017 | K173685 | Peel-Away Introducer Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 15, 2017 | K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| November 15, 2017 | K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 13, 2017 | K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter | FGE | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| October 4, 2017 | K172092 | Reprocessed Shavers/Burs | HRX | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| September 28, 2017 | K170020 | Peel-Away Introducer Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 21, 2017 | K161719 | Salter Labs Bubble Humidifier | BTT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| September 14, 2017 | K171953 | Bard Mission Disposable Core Biopsy Instrument | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| August 21, 2017 | K171897 | Approach CTO Microwire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 17, 2017 | K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | BWC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 23, 2016 | K153571 | Cavilon Advanced High Endurance Skin Protectant | KMF | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| March 10, 2016 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| February 17, 2016 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | GAR | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 5, 2015 | K143700 | CPAP Cannulaide | BZD | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| July 28, 2015 | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 4, 2014 | K143145 | SafeAir Smoke Pencil | GEI | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| November 18, 2014 | K140085 | UNIVERSA PERCULTANEOUS DRAINAGE CATHETER | FEW | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 3, 2014 | K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | DXO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 21, 2014 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| December 31, 2013 | K133806 | M1 CAPNOGRAPHY MASK | CCK | Substantially Equivalent | Monitor Mask, Inc. | accessdata.fda.gov |
| May 16, 2013 | K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | GAW | Substantially Equivalent | Surgical Specialties Corp. Dba Angiotech | accessdata.fda.gov |
| April 25, 2013 | K123527 | AIRLIFE | CAF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| October 3, 2012 | K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF | DXQ | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| February 10, 2012 | K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | BTT | Substantially Equivalent | Salter Labs, Arvin Facility | accessdata.fda.gov |
| October 7, 2011 | K111640 | PRECISION FLOW(R) - HELIOX | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| April 13, 2011 | K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| January 6, 2011 | K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| November 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| September 20, 2010 | K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| March 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| February 23, 2009 | K083641 | BIVONA TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 17, 2008 | K072845 | PRECISION FLOW | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| December 18, 2007 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| October 12, 2007 | K070414 | GAMBRO CARTRIDGE BLOOD SETS | FJK | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| April 27, 2007 | K070876 | STRYKER TWIST DRILLS | HBE | Substantially Equivalent | Stryker Craniomaxillofacial | accessdata.fda.gov |
| December 1, 2006 | K063485 | LOGIC LAPAROSCOPIC SCISSORS | GEI | Substantially Equivalent | Surgical Innovations Plc | accessdata.fda.gov |
| September 6, 2006 | K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | FER | Substantially Equivalent | Cook Ireland, Ltd. | accessdata.fda.gov |
| June 20, 2005 | K051367 | PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| May 25, 2005 | K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC | CCL | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 13, 2005 | K051076 | ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| May 11, 2005 | K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE | KNT | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| October 8, 2004 | K042410 | BAXJECT II | LHI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 3, 2004 | K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| December 30, 2003 | K033754 | TRACER METRO SMART WIRE GUIDE | OCY | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| June 11, 2003 | K024010 | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | The Kendall Company Div. of Tyco Healthcare Group | accessdata.fda.gov |
| February 27, 2003 | K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | LJE | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| February 14, 2002 | K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR | FTA | Substantially Equivalent | Aspen Surgical Products, Inc. | accessdata.fda.gov |
| March 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | MQM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 5, 2000 | K002768 | ACAPELLA | BWF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| August 17, 2000 | K001858 | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | KKX | Substantially Equivalent | China Nantong Guangda Textile Co., Ltd. | accessdata.fda.gov |
| June 15, 2000 | K001545 | PIPET CURET | HHK | Substantially Equivalent | Milex Products, Inc. | accessdata.fda.gov |
| November 24, 1999 | K992257 | NEW MULTIPLES REAGENT STRIPS | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| August 27, 1999 | K991729 | FERRIS POLYOSTOMY STERILE WOUND DRESSING | KMF | Substantially Equivalent | Ferris Mfg. Corp. | accessdata.fda.gov |
| April 30, 1999 | K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| January 22, 1999 | K984577 | DRAGER OXYLOG 2000 | CBK | Substantially Equivalent | Drager, Inc. | accessdata.fda.gov |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| January 30, 1998 | K980005 | MANAN D BAG | EXF | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| April 17, 1996 | K953522 | USCI IDEAL PTCA KIT | MAV | Substantially Equivalent | Ryder Intl. Corp. | accessdata.fda.gov |
| February 5, 1996 | K955103 | 3M NO STING BARRIER FILM | KMF | Substantially Equivalent | 3M Medical Products Group | accessdata.fda.gov |
| August 11, 1995 | K945660 | AUTOJECT 2 | KZH | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| October 27, 1994 | K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| June 7, 1994 | K932913 | FERRIS POLYMEM HYDROPHILIC WOUND DRESSING | KMF | Substantially Equivalent for Some Indications | Ferris Mfg. Corp. | accessdata.fda.gov |
| September 1, 1993 | K914419 | AMNIOTEST(TM) | HIO | Substantially Equivalent | Pro-Lab, Inc. | accessdata.fda.gov |
| October 23, 1991 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| August 26, 1991 | K911427 | BREATHING FILTERS | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| July 24, 1991 | K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | CAT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| October 31, 1990 | K904185 | SENSATRACE | DRX | Substantially Equivalent | Ludlow Corp., Technical Papers Division | accessdata.fda.gov |
| May 12, 1987 | K871412 | CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO | DRX | Substantially Equivalent | Contour Electrodes, Inc. | accessdata.fda.gov |
| September 9, 1986 | K863280 | DERMAMARKER | FZZ | Substantially Equivalent | Dermacare Products, Inc. | accessdata.fda.gov |
| June 11, 1984 | K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 4, 1983 | K831931 | ATRIUM THORACIC CATHETER | GBZ | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| January 17, 1983 | K823882 | M-BRACE | IPY | Substantially Equivalent | Buckman Consultants | accessdata.fda.gov |
| January 5, 1983 | K823707 | HOSPAL BLOOD LINES | KOC | Substantially Equivalent | Hospal Medical Corp. | accessdata.fda.gov |
| November 27, 1981 | K813140 | VYGON EXTENSION TUBES & CONNECTORS | DQO | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| November 27, 1979 | K792218 | MISTY BEBULIZER | CAF | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| September 24, 1979 | K791495 | LUKENS BONE WAX (GAMMA RADIATION) | MTJ | Substantially Equivalent | Lukens Corp. | accessdata.fda.gov |
| February 13, 1979 | K781922 | PULMONARY MONITOR | BZH | Substantially Equivalent | Vitalograph , Ltd. | accessdata.fda.gov |
| October 17, 1978 | K781548 | UMBILICAL CORD CLAMP | HFW | Substantially Equivalent | Hollister, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 27, 2017 | P160022 | X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower | MKJ | 52 | October 16, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Mask, Oxygen
- All makers of Clamp, Umbilical
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.