Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clement Clarke, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
539 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961512 | PERKINS HAND-HELD APPLANATION TONOMETER | Clement Clarke, Inc. | 1996-07-18 | 90 | 0 |
| K952713 | MINI WRIGHT LR AFS | Clement Clarke, Inc. | 1996-03-29 | 289 | 0 |
| K953965 | 904 SLIT LAMP | Clement Clarke, Inc. | 1995-09-27 | 36 | 0 |
| K932258 | OPTICOM M600 | Clement Clarke, Inc. | 1994-07-25 | 441 | 0 |
| K914126 | VMX MINI-LOG FLOWMETER | Clement Clarke, Inc. | 1993-03-05 | 539 | 0 |
| K914896 | FRIEDMANN ANALYSER 3 | Clement Clarke, Inc. | 1992-01-23 | 84 | 0 |
| K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE | Clement Clarke, Inc. | 1991-10-23 | 148 | 0 |
| K895953 | WRIGHT VENTILOMETER VM-1 | Clement Clarke, Inc. | 1990-02-02 | 114 | 0 |
| K841430 | LASERSPEC | Clement Clarke, Inc. | 1984-12-13 | 251 | 0 |
| K781313 | VISION-STIMULATOR, CAM | Clement Clarke, Inc. | 1979-01-26 | 179 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda