Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Anhui Tiankang Medical Technology Co., Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
201 daysmedian FDA review time
434 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 | 337 | 0 |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 | 337 | 0 |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-12 | 145 | 0 |
| K222385 | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2022-12-06 | 120 | 0 |
| K220204 | Disposabel Syringe with permanently attached needle, Safety | Anhui Tiankang Medical Technology Co., Ltd. | 2022-07-14 | 170 | 0 |
| K212368 | Surgical Face Mask | Anhui Tiankang Medical Technology Co., Ltd. | 2021-10-24 | 86 | 0 |
| K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2021-08-24 | 189 | 0 |
| K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. | 2020-09-11 | 450 | 0 |
| K191640 | TK Intravascular Administration Set | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-26 | 434 | 0 |
| K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-06 | 414 | 0 |
| K191642 | TK Sterile Piston Syringe without Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020-01-06 | 201 | 0 |
| K191643 | TK Sterile Hypodermic Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2019-12-19 | 183 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda