Anhui Jbh Medical Apparatus Co., Ltd.: FDA clearances and approvals
Anhui Jbh Medical Apparatus Co., Ltd. has 10 FDA 510(k) clearances (first 2021, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time: 136 days. Since 2017 its median was 136 days, against 135 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 100 |
| 2022 | 2 | 297 |
| 2023 | 0 | — |
| 2024 | 3 | 133 |
| 2025 | 3 | 139 |
| 2026 | 1 | 107 |
Review time against the same product codes
Since 2017, Anhui Jbh Medical Apparatus Co., Ltd.'s cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 6 | 6 |
| INI | Vehicle, Motorized 3-Wheeled | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
Most recent Anhui Jbh Medical Apparatus Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | INI | 2026-09-19 | 107 |
| K251606 | Power Wheelchair (D26) | ITI | 2025-06-25 | 29 |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | IOR | 2025-02-28 | 289 |
| K242448 | Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) | ITI | 2025-01-02 | 139 |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37) | ITI | 2024-12-31 | 133 |
| K242252 | Power Wheelchair | ITI | 2024-12-27 | 149 |
| K241854 | Power Wheelchair | ITI | 2024-10-04 | 99 |
| K212092 | Portable Folding Electric Wheelchair (Model: DC01) | ITI | 2022-05-06 | 304 |
| K212090 | Electric Scooter | INI | 2022-04-22 | 290 |
| K210302 | Disposable Medical mask | FXX | 2021-05-14 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Anhui Jbh Medical Apparatus Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Anhui Jbh Medical Apparatus Co., Ltd. have?
Anhui Jbh Medical Apparatus Co., Ltd. has 10 FDA 510(k) clearances (first 2021, latest 2026), across 4 product codes in 2 review panels.
How long does FDA take to clear Anhui Jbh Medical Apparatus Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Anhui Jbh Medical Apparatus Co., Ltd.'s cleared 510(k)s is 136 days. Since 2017: 136 days, versus 135 days for all cleared 510(k)s in the same product codes.
What devices does Anhui Jbh Medical Apparatus Co., Ltd. make?
Its most frequent FDA product codes are ITI (Wheelchair, Powered, 6); INI (Vehicle, Motorized 3-Wheeled, 2); FXX (Mask, Surgical, 1).
Has Anhui Jbh Medical Apparatus Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Anhui Jbh Medical Apparatus Co., Ltd. Related entities may recall under other names.
Next steps
- See all 10 Anhui Jbh Medical Apparatus Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Anhui Jbh Medical Apparatus Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.