Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterling Drug, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
86 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901369 | GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II | Sterling Drug, Inc. | 1990-06-05 | 74 | 0 |
| K896110 | BIOBRANE(R) II | Sterling Drug, Inc. | 1989-11-28 | 36 | 0 |
| K875275 | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | Sterling Drug, Inc. | 1988-01-27 | 34 | 0 |
| K840260 | PERIOGRAF DURAPATITE 40-60 MESH | Sterling Drug, Inc. | 1984-04-05 | 86 | 0 |
| K820164 | EMPTY STERILE CARPUJECT | Sterling Drug, Inc. | 1982-02-24 | 35 | 0 |
| K820023 | CONAGRAF TM DURAPATITE CONES | Sterling Drug, Inc. | 1982-02-24 | 50 | 0 |
| K813257 | ALVEOGRAF DURAPATITE(18-40 MESH) | Sterling Drug, Inc. | 1982-01-05 | 47 | 0 |
| K813070 | PERIOGRAF | Sterling Drug, Inc. | 1981-11-20 | 18 | 0 |
| K780209 | DILUTION SPIKE | Sterling Drug, Inc. | 1978-04-10 | 63 | 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