Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Warepalmy Enterprise, LLC (Usa) — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
203 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012792 | C.T.M. MOBITIY SCOOTER MODEL #HS-360 | Warepalmy Enterprise, LLC (Usa) | 2001-10-24 | 65 | 0 |
| K012791 | C.T.M. MOBILITY SCOOTER MODEL # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001-10-24 | 65 | 0 |
| K002983 | C.T.M. POWER CHAIR, MODEL HS-5600 | Warepalmy Enterprise, LLC (Usa) | 2000-10-11 | 16 | 0 |
| K000354 | C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 | Warepalmy Enterprise, LLC (Usa) | 2000-08-25 | 203 | 0 |
| K000356 | C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 | Warepalmy Enterprise, LLC (Usa) | 2000-08-25 | 203 | 0 |
| K983662 | C.T.M. MOBILITY SCOOTER, MODEL # HS-686 | Warepalmy Enterprise, LLC (Usa) | 1998-12-18 | 60 | 0 |
| K983663 | C.T.M. MOBILITY SCOOTER, MODEL # HS-666 | Warepalmy Enterprise, LLC (Usa) | 1998-12-18 | 60 | 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