Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hunan Accurate Bio-Medical Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
241 daysmedian FDA review time
334 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A- | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-05-14 | 269 | 0 |
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 | 241 | 0 |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximet | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025-01-02 | 97 | 0 |
| K240808 | Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2024-10-03 | 192 | 0 |
| K171241 | Pulse Oximeter | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2018-03-27 | 334 | 0 |
| K141105 | PULSE OXIMETER | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2014-12-04 | 219 | 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