Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Allercare/Nsl, 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) |
|---|---|---|---|---|---|
| K901667 | LATEX CONDOMS - CODE NO. 401, 421 & 1002 | Allercare/Nsl, Inc. | 1990-05-16 | 36 | 0 |
| K901668 | LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 | Allercare/Nsl, Inc. | 1990-05-16 | 36 | 0 |
| K901669 | LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000 | Allercare/Nsl, Inc. | 1990-05-16 | 36 | 0 |
| K901696 | LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033 | Allercare/Nsl, Inc. | 1990-05-16 | 34 | 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