Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterling Medivations, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
71 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021530 | SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJE | Sterling Medivations, Inc. | 2002-05-21 | 11 | 0 |
| K021487 | SIMPLICITY EASY ACCESS P INFUSION SET | Sterling Medivations, Inc. | 2002-05-17 | 9 | 0 |
| K021296 | SIMPLICITY QD EASY P INFUSION SET | Sterling Medivations, Inc. | 2002-05-14 | 20 | 0 |
| K021216 | SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PA | Sterling Medivations, Inc. | 2002-05-03 | 16 | 0 |
| K021005 | SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR I | Sterling Medivations, Inc. | 2002-04-25 | 28 | 0 |
| K020990 | SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJEC | Sterling Medivations, Inc. | 2002-04-10 | 14 | 0 |
| K020912 | SIMPLICITY EASY SOFT INFUSION SET | Sterling Medivations, Inc. | 2002-04-10 | 21 | 0 |
| K020629 | SIMPLICITY SIMPLEX SOFT INFUSION SET | Sterling Medivations, Inc. | 2002-04-01 | 34 | 0 |
| K014061 | SIMPLICITY STARPLUS SOFT INFUSION SET | Sterling Medivations, Inc. | 2002-01-17 | 38 | 0 |
| K014062 | SIMPLICITY EASY ACCESS INFUSION SET | Sterling Medivations, Inc. | 2002-01-17 | 38 | 0 |
| K013767 | SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, IN | Sterling Medivations, Inc. | 2001-12-12 | 29 | 0 |
| K013502 | SIMPLICITY CLASSIC WING QD INFUSION SET | Sterling Medivations, Inc. | 2001-12-03 | 42 | 0 |
| K013104 | SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABE | Sterling Medivations, Inc. | 2001-10-02 | 15 | 0 |
| K012845 | SIMPLICITY SOFT QD MICRO INFUSION SET | Sterling Medivations, Inc. | 2001-09-14 | 22 | 0 |
| K012330 | SIMPLICITY EURO QD INFUSION SET | Sterling Medivations, Inc. | 2001-08-10 | 18 | 0 |
| K011187 | SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PAR | Sterling Medivations, Inc. | 2001-06-19 | 62 | 0 |
| K011580 | SIMPLICITY SOFT QD SILVER INFUSION SET | Sterling Medivations, Inc. | 2001-06-05 | 14 | 0 |
| K010886 | SIMPLICITY WING INFUSION SET | Sterling Medivations, Inc. | 2001-04-30 | 38 | 0 |
| K010788 | SIMPLICITY SOFT QD EASY INFUSION SET | Sterling Medivations, Inc. | 2001-04-20 | 36 | 0 |
| K010676 | SIMPLICITY WINGED QD INFUSION SET | Sterling Medivations, Inc. | 2001-04-18 | 43 | 0 |
| K010647 | SIMPLICITY INFUSER INFUSION SET | Sterling Medivations, Inc. | 2001-04-13 | 39 | 0 |
| K010846 | SIMPLICITY SILVER SET SOFT INFUSION | Sterling Medivations, Inc. | 2001-04-12 | 22 | 0 |
| K010373 | SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFU | Sterling Medivations, Inc. | 2001-03-13 | 34 | 0 |
| K002127 | INJECTRITE-C15 AND INJECTRITE-C30 | Sterling Medivations, Inc. | 2000-12-29 | 168 | 0 |
| K003283 | SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) | Sterling Medivations, Inc. | 2000-12-13 | 55 | 0 |
| K002492 | SIMPLICITY SOFT INFUSION SET | Sterling Medivations, Inc. | 2000-10-24 | 71 | 0 |
| K002180 | SIMPLICITY DISPOSABLE PEN NEEDLE | Sterling Medivations, Inc. | 2000-10-13 | 86 | 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