Data / Medical devices / United Kingdom / Purebrand Slutions Ltd
Purebrand Slutions Ltd: FDA-registered device maker in London England, United Kingdom, 53 510(k) clearances
Purebrand Slutions Ltd is registered with the FDA (registration 3041276591) in London England, United Kingdom. It lists 67 device types. The FDA files 53 510(k) clearances under its listings, the newest dated March 13, 2026. 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
- 3041276591
- Address
- 13 Hawley Crescent Work Life, London England, United Kingdom, NW1 8NP
- Owner or operator
- Purebrand Solutions LTD (10094042)
- Roles
- Exporter to the US
- First device listed
- September 28, 2025
- Registered through
- 2026
- Brand names listed
- 3M INDICATOR,PHYSICAL/CHEMICAL STERILIZATION TAPE, BD CONTAINER, SPECIMEN TRANSPORT, BD HOLDER, BLOOD SPECIMEN COLLECTION, BD NEEDLE, SINGLE LUMEN, HYPODERMIC, BD NEURA/ PERIGUARD CATHETER SYSTEM, BD PLASTIPAK,SYRINGE, PISTON, BD SYRINGE, PISTON, BD TUBE, CONTAINER, VACUTAINER 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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 16, 2025 | K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | DXQ | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 29, 2025 | K251350 | BD Plastipak Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 1, 2024 | K242320 | BD Vacutainer® One Use Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 8, 2024 | K240229 | Masimo W1 | DPS | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 20, 2023 | K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 27, 2023 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 23, 2022 | K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 8, 2022 | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 | DQA | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| August 19, 2021 | K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | HIF | Substantially Equivalent | Conmed Corporation | 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 |
| July 28, 2017 | K171602 | Williams Cystoscopic Injection Needle | FBK | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 6, 2017 | K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | PIF | Substantially Equivalent | Xeridiem Medical Devices | accessdata.fda.gov |
| August 25, 2016 | K160379 | Exufiber Ag+ | FRO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| February 12, 2014 | K130040 | MEPITEL AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| April 5, 2013 | K123892 | MEPILEX TRANSFER AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| January 10, 2013 | K122687 | BLOOD CULTURE HOLDER | JKA | Substantially Equivalent | Greiner Bio-One North America, Inc. | accessdata.fda.gov |
| March 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| September 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| July 9, 2010 | K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | DXN | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 4, 2009 | K090938 | FLOW CONTROLLER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| April 24, 2008 | K080235 | SAFETY INFUSION SET | FMI | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| August 3, 2007 | K063835 | ALLEVYN AG DRESSING | FRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 13, 2007 | K071354 | MEPILEX AG DRESSING | FRO | Substantially Equivalent | Monlycke Health Care | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| August 17, 2001 | K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| October 6, 2000 | K001519 | ACTICOAT 7 DRESSING | FRO | Substantially Equivalent | Westaim Biomedical, Inc. | accessdata.fda.gov |
| October 28, 1998 | K983184 | MEPILEX | MGP | Substantially Equivalent | Molnlycke Health Care, Inc. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 3, 1998 | K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 30, 1995 | K953790 | BD PERISAFE EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 10, 1995 | K952578 | WELCH ALLY OTOSCOPE | ERA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| April 25, 1995 | K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | KNY | Substantially Equivalent | The Kendal Co. | accessdata.fda.gov |
| July 23, 1993 | K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | GAZ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| November 3, 1992 | K921493 | LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 | KZF | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| March 25, 1992 | K914604 | MEPITEL NON-ADHERENT SILICONE DRESSING | NAB | Substantially Equivalent | Molnlycke Clinical Products AB | accessdata.fda.gov |
| July 18, 1990 | K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE | DRX | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| May 18, 1990 | K900786 | VISI-SORB ABSORBANT STICK | HOZ | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| April 9, 1990 | K896323 | WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS | FGE | Substantially Equivalent | Wilson-Cook Medical, Inc. | accessdata.fda.gov |
| December 14, 1989 | K895408 | OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) | KGX | Substantially Equivalent | Smith & Nephew United, Inc. | accessdata.fda.gov |
| July 23, 1985 | K852588 | MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| November 8, 1984 | K842967 | AQUAPHOR R GAUZE | FRO | Substantially Equivalent | Beiersdorf, Inc. | accessdata.fda.gov |
| September 12, 1983 | K831875 | BALLOON DILATION HELICAL STONE EXTRACT | FFL | Substantially Equivalent | Vpi | accessdata.fda.gov |
| December 18, 1981 | K813278 | VPI URETERAL DILATATION BALLON CATHETER | EZN | Substantially Equivalent | Vance Products, Inc. | accessdata.fda.gov |
| June 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| February 19, 1981 | K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | FER | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 20, 1978 | K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | JOW | Substantially Equivalent | Kendall Research Center | accessdata.fda.gov |
| July 11, 1977 | K771189 | HOT TEMP CAUTERY | HQP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| June 15, 1977 | K770362 | TAPE, DERMICEL, CLOTH | KGX | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Catheter, Ureteral
- All makers of Knife, Ophthalmic
- All makers of Device, Medical Examination, Ac Powered
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Cannula, Nasal, Oxygen
- All makers of Blood Pressure Cuff
Updated March 13, 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.