Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
9th Wave, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963620 | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | 9th Wave, Inc. | 1997-01-07 | 119 | 0 |
| K963677 | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | 9th Wave, Inc. | 1996-11-26 | 74 | 0 |
| K963626 | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS | 9th Wave, Inc. | 1996-11-26 | 76 | 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