Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instrumed, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
459 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952038 | CLEAN-CUFF | Instrumed, Inc. | 1995-07-11 | 71 | 1 |
| K940615 | ACCUTEST | Instrumed, Inc. | 1995-05-19 | 459 | 0 |
| K924273 | ACCUFLATE | Instrumed, Inc. | 1993-01-12 | 141 | 3 |
| K924373 | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | Instrumed, Inc. | 1992-11-25 | 89 | 0 |
| K910512 | ACCUFLATE | Instrumed, Inc. | 1991-02-19 | 14 | 0 |
| K890014 | DISPOSABLE COLOR-CUFFS | Instrumed, Inc. | 1989-01-24 | 21 | 0 |
| K860617 | POLYPET | Instrumed, Inc. | 1986-03-03 | 12 | 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