Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Karma Medical Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
231 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202506 | Karma Powered Wheelchair | Karma Medical Products Co., Ltd. | 2021-04-19 | 231 | 0 |
| K062309 | KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 | Karma Medical Products Co., Ltd. | 2006-10-10 | 63 | 0 |
| K062311 | KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 | Karma Medical Products Co., Ltd. | 2006-10-04 | 57 | 0 |
| K041677 | KARMA SCOOTER, MODEL KS-747.2 | Karma Medical Products Co., Ltd. | 2004-08-05 | 45 | 0 |
| K041678 | KARMA POWER WHEELCHAIR, MODEL KP-25 | Karma Medical Products Co., Ltd. | 2004-07-23 | 32 | 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