Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avocet Medical, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994006 | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE | Avocet Medical, Inc. | 2000-02-03 | 71 | 0 |
| K991286 | AVOCET ACUSURE SYSTEM | Avocet Medical, Inc. | 1999-11-18 | 217 | 0 |
| K980839 | AVOCET PT | Avocet Medical, Inc. | 1998-09-30 | 210 | 0 |
| K980982 | AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 | Avocet Medical, Inc. | 1998-04-16 | 30 | 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