Clement Clarke Intl., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Clement Clarke Intl., Ltd.” (first 1997, latest 2006), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 143 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | 4 | 4 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
Review panels
- Anesthesiology (5)
- Ophthalmic (1)
Most recent Clement Clarke Intl., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | BZH | 2006-01-31 | 78 |
| K042058 | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN | BZG | 2005-03-23 | 236 |
| K000368 | EYECAP IMAGING SYSTEM | HKI | 2000-05-04 | 90 |
| K982334 | AIRZONE PEAK FLOWMETER | BZH | 1999-01-14 | 196 |
| K980960 | IN-CHECK INSPIRATORY FLOWMETER | BZH | 1998-06-10 | 86 |
| K962074 | VM PLUS PEAK FLOWMETER | BZH | 1997-01-02 | 219 |
Recalls
openFDA lists no recalls under a recalling firm named Clement Clarke Intl., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Clement Clarke, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clement Clarke Intl., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Clement Clarke Intl., Ltd.” (first 1997, latest 2006), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Clement Clarke Intl., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clement Clarke Intl., Ltd. is 143 days.
Which FDA product codes appear under Clement Clarke Intl., Ltd.?
The most frequent FDA product codes under this applicant name are BZH (Meter, Peak Flow, Spirometry, 4); BZG (Spirometer, Diagnostic, 1); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Next steps
- See all 6 Clement Clarke Intl., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZH, Clement Clarke Intl., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.