Berpu Medical Technology Co., Ltd.: FDA clearances and approvals
Berpu Medical Technology Co., Ltd. has 9 FDA 510(k) clearances (first 2016, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time: 209 days. Since 2017 its median was 217 days, against 174 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 147 |
| 2017 | 0 | — |
| 2018 | 1 | 175 |
| 2019 | 1 | 284 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 5 | 225 |
| 2023 | 0 | — |
| 2024 | 1 | 195 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Berpu Medical Technology Co., Ltd.'s cleared 510(k)s took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| MEG | Syringe, Antistick | 2 | 2 |
Review panels
- General Hospital (9)
Most recent Berpu Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | FMI | 2024-02-01 | 195 |
| K221045 | Insulin Syringes without needle | FMF | 2022-11-03 | 209 |
| K220061 | Safety Insulin Syringes | MEG | 2022-08-23 | 225 |
| K213158 | Syringe with permanently attached needle | FMF | 2022-07-21 | 296 |
| K213811 | Sterile Hypodermic Syringes for Single Use | FMF | 2022-05-12 | 156 |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | FMI | 2022-04-29 | 262 |
| K181447 | Safety insulin needle for single use | FMI | 2019-03-12 | 284 |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use | MEG | 2018-08-09 | 175 |
| K162180 | Disposable Insulin Syringe | FMF | 2016-12-29 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Berpu 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 Berpu Medical Technology Co., Ltd. have?
Berpu Medical Technology Co., Ltd. has 9 FDA 510(k) clearances (first 2016, latest 2024), across 3 product codes in 1 review panel.
How long does FDA take to clear Berpu Medical Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Berpu Medical Technology Co., Ltd.'s cleared 510(k)s is 209 days. Since 2017: 217 days, versus 174 days for all cleared 510(k)s in the same product codes.
What devices does Berpu Medical Technology Co., Ltd. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 4); FMI (Needle, Hypodermic, Single Lumen, 3); MEG (Syringe, Antistick, 2).
Has Berpu Medical Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Berpu Medical Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 9 Berpu Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Berpu 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.