Data / Medical devices / United Kingdom / Flexicare Medical Ltd.
Flexicare Medical Ltd.: FDA-registered device maker in RHONDDA CYNON TAFF Wales, United Kingdom, 24 510(k) clearances
Flexicare Medical Ltd. is registered with the FDA (registration 8021995) in RHONDDA CYNON TAFF Wales, United Kingdom. It lists 49 device types. The FDA files 24 510(k) clearances under its listings, the newest dated September 2, 2026. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8021995
- FEI number
- 3006363476
- Address
- Cynon Valley Business Park Mountain Ash, RHONDDA CYNON TAFF Wales, United Kingdom, CF45 4ER
- Owner or operator
- FLEXICARE MEDICAL LTD. (8021995)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- August 30, 2006
- Registered through
- 2026
- Brand names listed
- 2106570-008 BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE, Barr-Vent, BriteBlade Pro, BritePro Omni, BritePro Solo, CAPNOCARE MONITORING LINE WITH CONICAL CONNECTOR, CO2 monitoring, CO2 monitoring Line 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 |
|---|---|---|---|---|---|---|
| September 2, 2026 | K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | EOQ | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| January 16, 2026 | K251448 | FL-10000U Respiratory Humidifier | BTT | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| May 20, 2025 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | BTR | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| November 13, 2020 | K201666 | SINGLE USE MANOMETER | CAP | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| March 23, 2020 | K191909 | HepaShield Bacterial Viral Breathing System Filter | CAH | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| December 7, 2018 | K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | BTM | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| March 22, 2017 | K163300 | ThermoShield HME Filter | CAH | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| July 6, 2016 | K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | BTT | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| June 23, 2016 | K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | BZE | Substantially Equivalent | Flexicare Medical Limited. | accessdata.fda.gov |
| May 15, 2015 | K150900 | Flexicare Heated Wire Breathing Systems | BZE | Substantially Equivalent | Flexicare Medical, Ltd. | accessdata.fda.gov |
| April 30, 2014 | K133516 | CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER | CCK | Substantially Equivalent | Flexicare | accessdata.fda.gov |
| April 10, 2014 | K140473 | DUALGUARD | CCK | Substantially Equivalent | Flexicare Medical, Ltd. | accessdata.fda.gov |
| March 6, 2014 | K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | CCK | Substantially Equivalent | Flexicare Medical, Ltd. | accessdata.fda.gov |
| August 29, 2013 | K122885 | MEDISIZE GOLD HEATER AND BOOSTER T-PIECE | BTT | Substantially Equivalent | Medisize BV | accessdata.fda.gov |
| May 23, 2013 | K123937 | ATOM TRANSCAPSULE V-707 | FPL | Substantially Equivalent | Atom Medical Corporation | accessdata.fda.gov |
| November 4, 2011 | K110246 | MEDISIZE RED AND MEDISIZE BLUE | CAH | Substantially Equivalent | Qserve America, Inc. | accessdata.fda.gov |
| July 1, 2011 | K102719 | ATLANTEAN TRIGGER NEBULIZER | CAF | Substantially Equivalent | Atlantean Corporation | accessdata.fda.gov |
| April 20, 2011 | K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP | BYE | Substantially Equivalent | Neoforce Group, Inc. | accessdata.fda.gov |
| October 6, 2009 | K092218 | FLEXICARE BREATHING FILTERS | CAH | Substantially Equivalent | Flexicare Medical, Ltd. | accessdata.fda.gov |
| June 17, 2009 | K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Flexicare Medical, Ltd. | accessdata.fda.gov |
| January 23, 2009 | K081536 | MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED | CAH | Substantially Equivalent | Medisize BV | accessdata.fda.gov |
| September 12, 2007 | K072021 | NEOPIP INFANT RESUSCITATOR | BTM | Substantially Equivalent | Neoforce Group, Inc. | accessdata.fda.gov |
| December 9, 2005 | K052615 | MEDISIZE GOLD | BTT | Substantially Equivalent | Medisize BV | accessdata.fda.gov |
| March 1, 1999 | K983817 | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) | CAH | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 22, 2020 | 86484 | Class I | Terminated | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers | When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient. | accessdata.fda.gov |
| November 27, 2019 | 84367 | Class II | Terminated | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of th | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts. | accessdata.fda.gov |
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Updated September 2, 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.