Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymed Therapeutics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
413 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Ke | Polymed Therapeutics, Inc. | 2014-09-25 | 28 | 0 |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | 2014-01-09 | 121 | 0 |
| K121065 | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN D | Polymed Therapeutics, Inc. | 2013-05-24 | 413 | 0 |
| K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | Polymed Therapeutics, Inc. | 2013-03-14 | 174 | 0 |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. | 2012-07-17 | 361 | 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