Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cosmetic Sciences, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842756 | BUTTERFLY II PN INFUSION NEEDLE | Cosmetic Sciences, Inc. | 1984-07-23 | 7 | 0 |
| K833682 | PRIMARY PIGGYBACK INFUSION SET W/PERM | Cosmetic Sciences, Inc. | 1983-11-28 | 28 | 0 |
| K830568 | GUTTMAN INFUSION NEEDLE | Cosmetic Sciences, Inc. | 1983-10-27 | 247 | 0 |
| K822603 | PERMA-SET INFUSION SET | Cosmetic Sciences, Inc. | 1982-09-14 | 18 | 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