Karma Medical Products Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Karma Medical Products Co., Ltd.” (first 2004, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 231 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Karma Medical Products Co., Ltd. took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 2 | 2 |
| ITI | Wheelchair, Powered | 2 | 2 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
Review panels
Most recent Karma Medical Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202506 | Karma Powered Wheelchair | ITI | 2021-04-19 | 231 |
| K062309 | KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 | IOR | 2006-10-10 | 63 |
| K062311 | KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 | IOR | 2006-10-04 | 57 |
| K041677 | KARMA SCOOTER, MODEL KS-747.2 | INI | 2004-08-05 | 45 |
| K041678 | KARMA POWER WHEELCHAIR, MODEL KP-25 | ITI | 2004-07-23 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Karma Medical Products Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Karma Mobility Co, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Karma Medical Products Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Karma Medical Products Co., Ltd.” (first 2004, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Karma Medical Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Karma Medical Products Co., Ltd. is 57 days.
Which FDA product codes appear under Karma Medical Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 2); ITI (Wheelchair, Powered, 2); INI (Vehicle, Motorized 3-Wheeled, 1).
Next steps
- See all 5 Karma Medical Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Karma Medical Products Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.