BMC Medical Co., Ltd.: FDA clearances and approvals
BMC Medical Co., Ltd. has 7 FDA 510(k) clearances (first 2014, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 215 days. Since 2017 its median was 242 days, against 224 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named BMC Medical Co., Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 210 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 270 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 378 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 112 |
| 2026 | 2 | 210 |
Review time against the same product codes
Since 2017, BMC Medical Co., Ltd.'s cleared 510(k)s took a median 242 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 224 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 5 | 5 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 1 | 1 |
Review panels
- Anesthesiology (7)
Most recent BMC Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | CAW | 2026-08-14 | 205 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BZD | 2026-04-29 | 215 |
| K242935 | Respiration Data Management Software (PAP Link PC) | BZD | 2025-01-15 | 112 |
| K213169 | BPAP System | MNS | 2022-12-05 | 433 |
| K211155 | Auto CPAP System | BZD | 2022-03-09 | 324 |
| K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | BZD | 2017-09-05 | 270 |
| K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK | BZD | 2014-04-23 | 210 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-07-15.
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 BMC Medical Co., Ltd. have?
BMC Medical Co., Ltd. has 7 FDA 510(k) clearances (first 2014, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear BMC Medical Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across BMC Medical Co., Ltd.'s cleared 510(k)s is 215 days. Since 2017: 242 days, versus 224 days for all cleared 510(k)s in the same product codes.
What devices does BMC Medical Co., Ltd. make?
Its most frequent FDA product codes are BZD (Ventilator, Non-Continuous (Respirator), 5); CAW (Generator, Oxygen, Portable, 1); MNS (Ventilator, Continuous, Non-Life-Supporting, 1).
Has BMC Medical Co., Ltd. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches BMC Medical Co., Ltd; the most recent began 2026-07-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 BMC Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZD, BMC Medical 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.