Hunan Accurate Bio-Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hunan Accurate Bio-Medical Technology Co., Ltd.” (first 2014, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 230 days. Since 2017 the median was 241 days, against 206 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 219 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 334 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 192 |
| 2025 | 1 | 97 |
| 2026 | 2 | 255 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hunan Accurate Bio-Medical Technology Co., Ltd. took a median 241 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| HIR | Perineometer | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Hunan Accurate Bio-Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | KPI | 2026-05-14 | 269 |
| K252748 | Pelvic Floor Exerciser (PF01) | HIR | 2026-04-27 | 241 |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | DQA | 2025-01-02 | 97 |
| K240808 | Pulse Oximeter (WS20A) | DQA | 2024-10-03 | 192 |
| K171241 | Pulse Oximeter | DQA | 2018-03-27 | 334 |
| K141105 | PULSE OXIMETER | DQA | 2014-12-04 | 219 |
Recalls
openFDA lists no recalls under a recalling firm named Hunan Accurate Bio-Medical Technology 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 Hunan Accurate Bio-Medical Technology Co., Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
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.
- Hunan Vathin Medical Instrument Co., Ltd. (17 510(k)s)
- Hunan Endoso Life Technology Co., Ltd. (3 510(k)s)
- Hunan Eexi Technology & Service Co., Ltd. (2 510(k)s)
- Hunan Guangye Biotechnology Co., Ltd. (2 510(k)s)
- Hunan Handlike Minimally Invasive Surgery Co., Ltd. (2 510(k)s)
- Hunan Heng Chang Pharmaceutical Co., Ltd. (2 510(k)s)
- Hunan Qinghao Puzhong Technology Co., Ltd. (2 510(k)s)
- Hunan Vsmile Biotechnology Co., Ltd. (2 510(k)s)
- Hunan Zhenheyikang Medical Instrument Co., Ltd. (2 510(k)s)
- Hunan Ceramaster Material Technology Co., Ltd. (1 510(k)s)
- Hunan Chopard Medical Devices Co., Ltd. (1 510(k)s)
- Hunan Haipuming Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hunan Accurate Bio-Medical Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Hunan Accurate Bio-Medical Technology Co., Ltd.” (first 2014, latest 2026), across 3 product codes in 2 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 Hunan Accurate Bio-Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hunan Accurate Bio-Medical Technology Co., Ltd. is 230 days. Since 2017: 241 days, versus 206 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hunan Accurate Bio-Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); HIR (Perineometer, 1); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1).
Next steps
- See all 6 Hunan Accurate Bio-Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Hunan Accurate Bio-Medical Technology 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.