Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dermacare Products, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
24 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882494 | ELAN-E DISPOSALBE DRAPE | Dermacare Products, Inc. | 1988-07-08 | 22 | 0 |
| K882421 | INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE | Dermacare Products, Inc. | 1988-06-30 | 17 | 0 |
| K871910 | SURGITEK DISPOSABLE BIPOLAR CORD | Dermacare Products, Inc. | 1987-06-01 | 14 | 0 |
| K863280 | DERMAMARKER | Dermacare Products, Inc. | 1986-09-09 | 15 | 0 |
| K863279 | SURGI-TEK TUBE POSITIONER | Dermacare Products, Inc. | 1986-09-09 | 15 | 0 |
| K863278 | SURGI-WIPES | Dermacare Products, Inc. | 1986-09-02 | 8 | 0 |
| K862367 | PRO-CLEAN | Dermacare Products, Inc. | 1986-07-08 | 14 | 0 |
| K853374 | CORRECT-A-COUNT | Dermacare Products, Inc. | 1985-09-05 | 24 | 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