Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nms Pharmaceuticals, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
354 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861202 | TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS | Nms Pharmaceuticals, Inc. | 1987-01-09 | 284 | 0 |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | Nms Pharmaceuticals, Inc. | 1986-10-10 | 354 | 0 |
| K860828 | FORETEL, COLOR OVULATION TEST | Nms Pharmaceuticals, Inc. | 1986-08-04 | 152 | 0 |
| K853925 | QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA | Nms Pharmaceuticals, Inc. | 1985-12-02 | 69 | 0 |
| K851445 | COLOR OVULATION TEST | Nms Pharmaceuticals, Inc. | 1985-07-29 | 109 | 0 |
| K850431 | EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL | Nms Pharmaceuticals, Inc. | 1985-06-17 | 133 | 0 |
| K850786 | TOTAL HIGE ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | 1985-04-12 | 45 | 0 |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | 1985-03-26 | 28 | 0 |
| K842499 | NMS 1043 ENZYME IMMUNOASSAY KIT | Nms Pharmaceuticals, Inc. | 1984-09-14 | 80 | 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