Merits Health Products Co., Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Merits Health Products Co., Ltd.” (first 1993, latest 2022), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 87 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 | 1 | 155 |
| 2013 | 1 | 159 |
| 2014 | 0 | — |
| 2015 | 2 | 264 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 22 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Merits Health Products Co., Ltd. took a median 22 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 10 | 10 |
| INI | Vehicle, Motorized 3-Wheeled | 7 | 7 |
| CAW | Generator, Oxygen, Portable | 6 | 6 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| ILK | Transport, Patient, Powered | 1 | 1 |
| ING | Elevator, Wheelchair, Portable | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
Most recent Merits Health Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220529 | Merits P335 Powered Wheelchair | ITI | 2022-03-18 | 22 |
| K142912 | Merits Yoga Power Scooter, S542 | INI | 2015-06-23 | 260 |
| K142162 | MERITS TRANSFORMER POWER SCOOTER, S941 | INI | 2015-05-01 | 268 |
| K122357 | MERITS MODEL P322FWD POWERED WHEELCHAIR | ITI | 2013-01-09 | 159 |
| K113577 | MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR | ITI | 2012-05-08 | 155 |
| K092859 | MERITS MODEL N SERIES NEBULIZER COMPRESSORS | CAF | 2010-07-02 | 288 |
| K091716 | MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY | CAW | 2010-04-02 | 296 |
| K073110 | MERITS E600 SERIES STAIR LIFT | ILK | 2008-02-06 | 93 |
| K073513 | MERITS E700 PORCE LIFT | ING | 2008-01-14 | 31 |
| K053490 | MERITS HEALTH PRODUCTS PORTABLE NEBULIZER | CAF | 2006-07-24 | 221 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Merits Health 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Merits Health Products Co., Ltd. (a text match, not an official crosswalk):
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.
- Merits Healthcare Industries (Suzhou) Co., Ltd. (1 510(k)s)
- Merits Medical Industries Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merits Health Products Co., Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Merits Health Products Co., Ltd.” (first 1993, latest 2022), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Merits Health Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merits Health Products Co., Ltd. is 87 days.
Which FDA product codes appear under Merits Health Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 10); INI (Vehicle, Motorized 3-Wheeled, 7); CAW (Generator, Oxygen, Portable, 6).
Next steps
- See all 31 Merits Health Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Merits Health 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.