Clement Clarke, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Clement Clarke, Inc.” (first 1979, latest 1996), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 164 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 | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HKY | Tonometer, Manual | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
| HOK | Screen, Tangent, Projection, Ac-Powered | 1 | 1 |
| HPL | Device, Fixation, Ac-Powered, Ophthalmic | 1 | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (6)
- Anesthesiology (3)
Most recent Clement Clarke, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961512 | PERKINS HAND-HELD APPLANATION TONOMETER | HKY | 1996-07-18 | 90 |
| K952713 | MINI WRIGHT LR AFS | BZH | 1996-03-29 | 289 |
| K953965 | 904 SLIT LAMP | HJO | 1995-09-27 | 36 |
| K932258 | OPTICOM M600 | HPT | 1994-07-25 | 441 |
| K914126 | VMX MINI-LOG FLOWMETER | BZH | 1993-03-05 | 539 |
| K914896 | FRIEDMANN ANALYSER 3 | HOK | 1992-01-23 | 84 |
| K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE | HLI | 1991-10-23 | 148 |
| K895953 | WRIGHT VENTILOMETER VM-1 | BZG | 1990-02-02 | 114 |
| K841430 | LASERSPEC | — | 1984-12-13 | 251 |
| K781313 | VISION-STIMULATOR, CAM | HPL | 1979-01-26 | 179 |
Recalls
openFDA lists no recalls under a recalling firm named Clement Clarke, Inc..
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 Intl., Ltd. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clement Clarke, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Clement Clarke, Inc.” (first 1979, latest 1996), across 9 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clement Clarke, Inc. is 164 days.
Which FDA product codes appear under Clement Clarke, Inc.?
The most frequent FDA product codes under this applicant name are BZH (Meter, Peak Flow, Spirometry, 2); BZG (Spirometer, Diagnostic, 1); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 1).
Next steps
- See all 10 Clement Clarke, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZH, Clement Clarke, Inc.'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.