Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Berpu Medical Technology Co., Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
296 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hy | Berpu Medical Technology Co., Ltd. | 2024-02-01 | 195 | 0 |
| K221045 | Insulin Syringes without needle | Berpu Medical Technology Co., Ltd. | 2022-11-03 | 209 | 0 |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022-08-23 | 225 | 0 |
| K213158 | Syringe with permanently attached needle | Berpu Medical Technology Co., Ltd. | 2022-07-21 | 296 | 0 |
| K213811 | Sterile Hypodermic Syringes for Single Use | Berpu Medical Technology Co., Ltd. | 2022-05-12 | 156 | 0 |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | Berpu Medical Technology Co., Ltd. | 2022-04-29 | 262 | 0 |
| K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019-03-12 | 284 | 0 |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hyp | Berpu Medical Technology Co., Ltd. | 2018-08-09 | 175 | 0 |
| K162180 | Disposable Insulin Syringe | Berpu Medical Technology Co., Ltd. | 2016-12-29 | 147 | 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