Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acuderm, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
247 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933516 | ACU-E PUNCH | Acuderm, Inc. | 1994-03-24 | 247 | 0 |
| K933265 | ACU-DISPO-CE(TM) | Acuderm, Inc. | 1994-03-07 | 244 | 0 |
| K933137 | ACU-SUTURE KIT | Acuderm, Inc. | 1994-02-22 | 239 | 0 |
| K930043 | ACU-EVAC | Acuderm, Inc. | 1994-02-09 | 400 | 0 |
| K933866 | ACU-HEMOSTATIC RING | Acuderm, Inc. | 1993-12-01 | 117 | 0 |
| K915000 | ACU-GUARD | Acuderm, Inc. | 1992-01-27 | 81 | 0 |
| K891334 | ACU-CURETTE | Acuderm, Inc. | 1989-04-11 | 32 | 0 |
| K874024 | ACU-MICRO-NEEDLE | Acuderm, Inc. | 1987-11-23 | 52 | 0 |
| K854877 | ACU-SYRINGE W/WO NEEDLES | Acuderm, Inc. | 1986-02-19 | 75 | 0 |
| K832583 | SABOURAUD DEXTROSE AGAR | Acuderm, Inc. | 1983-09-12 | 41 | 0 |
| K832582 | MYCOSEL AGAR | Acuderm, Inc. | 1983-09-12 | 41 | 0 |
| K832581 | DTM-DERMATOPHYTE TEST MEDIUM | Acuderm, Inc. | 1983-09-12 | 41 | 0 |
| K831635 | ACU-PUNCH | Acuderm, Inc. | 1983-07-07 | 48 | 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