Data / Medical devices / United Kingdom / Clement Clarke Intl., Ltd.
Clement Clarke Intl., Ltd.: FDA-registered device maker in Mountain Ash Rhondda Cynon Taff, United Kingdom, 5 510(k) clearances
Clement Clarke Intl., Ltd. is registered with the FDA (registration 9610639) in Mountain Ash Rhondda Cynon Taff, United Kingdom. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610639
- FEI number
- 3002806708
- Address
- Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff, United Kingdom, CF45 4ER
- Owner or operator
- FLEXICARE MEDICAL LTD. (8021995)
- Roles
- Specification developer
- First device listed
- January 17, 2007
- Registered through
- 2026
- Brand names listed
- AIRZONE (MEDLINE) 12X36 BOX, AIRZONE BLUE ATS (EUROPE) CE, AIRZONE BLUE ATS (US) SINGLE, AIRZONE EVALUPEAK ATS CURAPLEX, AIRZONE WHITE (AIRIAL), FLEXICARE ANAESTHETIC MASKS, FLEXICARE MOUTHPIECE, FLEXICARE SILICONE ANAESTHETIC FACE MASKS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holding Chambers, Direct Patient Interface | NVP | 2 | Specification developer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Specification developer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Specification developer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Specification developer | accessdata.fda.gov |
| Percussor, Powered-Electric | BYI | 2 | Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| June 5, 2013 | K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Inspirx, Inc. | accessdata.fda.gov |
| January 14, 1999 | K982334 | AIRZONE PEAK FLOWMETER | BZH | Substantially Equivalent | Clement Clarke Intl., Ltd. | accessdata.fda.gov |
| June 10, 1998 | K980960 | IN-CHECK INSPIRATORY FLOWMETER | BZH | Substantially Equivalent | Clement Clarke Intl., Ltd. | accessdata.fda.gov |
| March 29, 1996 | K952713 | MINI WRIGHT LR AFS | BZH | Substantially Equivalent | Clement Clarke, Inc. | accessdata.fda.gov |
| May 24, 1994 | K940986 | FLUTTER(R) | BYI | Substantially Equivalent | Varioraw SA | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Gas, Anesthetic
- All makers of Meter, Peak Flow, Spirometry
- All makers of Percussor, Powered-Electric
- All makers of Mouthpiece, Breathing
- All makers of Holding Chambers, Direct Patient Interface
Updated June 5, 2013. 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.