Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rescare , Ltd. — 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) |
|---|---|---|---|---|---|
| K952429 | RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYST | Rescare , Ltd. | 1996-07-02 | 405 | 0 |
| K952475 | SULLIVAN NOSE & MOUTH MASK SYSTEM | Rescare , Ltd. | 1996-05-28 | 364 | 0 |
| K931884 | SULLIVAN NASAL VPAP SYSTEM | Rescare , Ltd. | 1994-06-07 | 418 | 0 |
| K930656 | SULLIVAN III NASAL CPAP SYSTEM | Rescare , Ltd. | 1994-03-15 | 399 | 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