Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Laboratories, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
175 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090358 | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC AC | Abbott Laboratories, Inc. | 2009-08-06 | 175 | 0 |
| K061193 | CREATININE | Abbott Laboratories, Inc. | 2006-06-23 | 56 | 0 |
| K051213 | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIP | Abbott Laboratories, Inc. | 2005-05-27 | 15 | 3 |
| K040954 | FOX PLUS PTA CATHETER | Abbott Laboratories, Inc. | 2004-05-11 | 28 | 0 |
| K040761 | AXSYM CYCLOSPORINE | Abbott Laboratories, Inc. | 2004-04-30 | 36 | 0 |
| K023062 | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MA | Abbott Laboratories, Inc. | 2002-09-30 | 14 | 1 |
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