Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LBE · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
281 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | 2023-08-31 | 281 | 0 |
| K130644 | PEDIATRIC FOLDING WHEELCHAIR | Columbia Medical Mfg, LLC | 2013-10-16 | 219 | 0 |
| K863450 | SULKY SPECIAL | Asc Corp. | 1986-10-23 | 50 | 0 |
| K862888 | PERAMBULATOR (STROLLER) | Mednet, Inc. | 1986-08-13 | 22 | 0 |
| K840250 | CARRIER | Convaid Products, Inc. | 1984-02-09 | 29 | 0 |
| K820591 | MECHANICAL CHAIR | Kaye Products, Inc. | 1982-03-15 | 11 | 0 |
| K810676 | CONVAID CRUISER CP4M | Convaid Products, Inc. | 1981-03-26 | 14 | 0 |
| K781947 | STROLLER, THERAPY | Convaid Products, Inc. | 1978-12-04 | 13 | 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