Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionike Laboratories, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
56 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993945 | BIONIKE AQ PHENCYCLIDINE (PCP) TEST | Bionike Laboratories, Inc. | 1999-12-07 | 18 | 0 |
| K972384 | AQ ONE STEP COCAINE TEST | Bionike Laboratories, Inc. | 1997-08-06 | 41 | 0 |
| K971841 | BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST | Bionike Laboratories, Inc. | 1997-06-25 | 37 | 0 |
| K971361 | AQ OPIATES (MORPHINE) TEST | Bionike Laboratories, Inc. | 1997-06-06 | 56 | 0 |
| K960992 | BIONIKE A/Q PREGNANCY TEST | Bionike Laboratories, Inc. | 1996-04-25 | 44 | 0 |
| K954901 | BIONIKE A/Q PREGNANCY TEST | Bionike Laboratories, Inc. | 1995-12-11 | 47 | 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