Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Germaine Laboratories, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
120 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051727 | AIMSTICK URINE REAGENT STRIPS | Germaine Laboratories, Inc. | 2005-10-26 | 120 | 0 |
| K013857 | AIMSTEP PREGNANCY | Germaine Laboratories, Inc. | 2002-01-22 | 62 | 0 |
| K991369 | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY | Germaine Laboratories, Inc. | 1999-05-10 | 20 | 0 |
| K981165 | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST | Germaine Laboratories, Inc. | 1998-04-16 | 16 | 0 |
| K980531 | AIMSTEP PREGNANCY | Germaine Laboratories, Inc. | 1998-03-06 | 23 | 0 |
| K974368 | AIMSTICK PBD PREGNANCY | Germaine Laboratories, Inc. | 1998-01-02 | 43 | 0 |
| K974512 | AIMSTICK PBD COMBO PREGNANCY | Germaine Laboratories, Inc. | 1998-01-02 | 32 | 0 |
| K973825 | MIDSTREAM HOME REGNANCY TEST | Germaine Laboratories, Inc. | 1997-12-19 | 73 | 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