Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Keymed (Medical & Industrial Equipment), Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
166 daysmedian FDA review time
406 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | Keymed (Medical & Industrial Equipment), Ltd. | 2010-09-13 | 166 | 3 |
| K011725 | OLYMPUS SUCTION PUMP, MODEL KV-5 | Keymed (Medical & Industrial Equipment), Ltd. | 2001-08-31 | 88 | 0 |
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 | Keymed (Medical & Industrial Equipment), Ltd. | 2000-05-12 | 50 | 1 |
| K962528 | OLYMPUS MOBILE CHAIR/COUCH | Keymed (Medical & Industrial Equipment), Ltd. | 1996-12-12 | 168 | 0 |
| K930852 | OLYMPUS SUCTION PUMP MODEL KV-4 | Keymed (Medical & Industrial Equipment), Ltd. | 1994-03-31 | 406 | 0 |
| K881478 | MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Keymed (Medical & Industrial Equipment), Ltd. | 1988-09-14 | 161 | 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