Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clement Clarke Intl., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
196 daysmedian FDA review time
236 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | Clement Clarke Intl., Ltd. | 2006-01-31 | 78 | 0 |
| K042058 | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN | Clement Clarke Intl., Ltd. | 2005-03-23 | 236 | 0 |
| K000368 | EYECAP IMAGING SYSTEM | Clement Clarke Intl., Ltd. | 2000-05-04 | 90 | 0 |
| K982334 | AIRZONE PEAK FLOWMETER | Clement Clarke Intl., Ltd. | 1999-01-14 | 196 | 0 |
| K980960 | IN-CHECK INSPIRATORY FLOWMETER | Clement Clarke Intl., Ltd. | 1998-06-10 | 86 | 0 |
| K962074 | VM PLUS PEAK FLOWMETER | Clement Clarke Intl., Ltd. | 1997-01-02 | 219 | 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