Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acon Laboratories Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
98 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090057 | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM | Acon Laboratories Co. | 2009-04-08 | 90 | 0 |
| K061559 | ACON URINALYSIS REAGENT STRIPS | Acon Laboratories Co. | 2006-08-11 | 67 | 1 |
| K023766 | ACON STREP A TWIST TEST DEVICE | Acon Laboratories Co. | 2003-02-10 | 90 | 1 |
| K020313 | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON O | Acon Laboratories Co. | 2002-05-08 | 98 | 0 |
| K010582 | ACON STREP A RAPID TEST STRIP | Acon Laboratories Co. | 2001-05-07 | 69 | 3 |
| K980736 | ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST | Acon Laboratories Co. | 1998-04-16 | 50 | 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