Anhui Tiankang Medical Technology Co., Ltd.: FDA clearances and approvals
Anhui Tiankang Medical Technology Co., Ltd. has 12 FDA 510(k) clearances (first 2019, latest 2023), across 9 product codes in 2 review panels. Median 510(k) review time: 195 days. Since 2017 its median was 195 days, against 163 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 183 |
| 2020 | 4 | 424 |
| 2021 | 2 | 138 |
| 2022 | 2 | 145 |
| 2023 | 3 | 337 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Anhui Tiankang Medical Technology Co., Ltd.'s cleared 510(k)s took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
| NGT | Saline, Vascular Access Flush | 1 | 1 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
| SCL | Allergen And Vaccine Delivery Needles | 1 | 1 |
Review panels
Most recent Anhui Tiankang Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222773 | Feeding Tube | PIF | 2023-08-17 | 337 |
| K222772 | Oral/Enteral Syringe with ENFit connector | PNR | 2023-08-17 | 337 |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | NGT | 2023-08-12 | 145 |
| K222385 | Bifurcated Needle | SCL | 2022-12-06 | 120 |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle | FMF | 2022-07-14 | 170 |
| K212368 | Surgical Face Mask | FXX | 2021-10-24 | 86 |
| K210464 | Auto Disable Syringe | FMF | 2021-08-24 | 189 |
| K191639 | TK Insulin Syringe with/without Saftey Retractable Device | MEG | 2020-09-11 | 450 |
| K191640 | TK Intravascular Administration Set | FPA | 2020-08-26 | 434 |
| K191644 | TK Safety Needle | FMI | 2020-08-06 | 414 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anhui Tiankang Medical Technology 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 Tiankang Medical Technology Co., Ltd. have?
Anhui Tiankang Medical Technology Co., Ltd. has 12 FDA 510(k) clearances (first 2019, latest 2023), across 9 product codes in 2 review panels.
How long does FDA take to clear Anhui Tiankang Medical Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Anhui Tiankang Medical Technology Co., Ltd.'s cleared 510(k)s is 195 days. Since 2017: 195 days, versus 163 days for all cleared 510(k)s in the same product codes.
What devices does Anhui Tiankang Medical Technology Co., Ltd. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 3); FMI (Needle, Hypodermic, Single Lumen, 2); FPA (Set, Administration, Intravascular, 1).
Has Anhui Tiankang Medical Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Anhui Tiankang Medical Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 12 Anhui Tiankang Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Anhui Tiankang Medical Technology 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.