New Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “New Medical Co., Ltd.” (first 2007, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 31 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 6 | 6 |
Review panels
- Radiology (6)
Most recent New Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120380 | SATURN 8000 | MQB | 2012-03-09 | 31 |
| K110210 | SATURN 8000-GS | MQB | 2011-04-20 | 85 |
| K080589 | SATURN 9000-810 | MQB | 2008-06-11 | 100 |
| K072984 | SATURN 9000-550 | MQB | 2007-11-14 | 22 |
| K072983 | SATURN 9000-750 | MQB | 2007-11-13 | 21 |
| K063710 | SATURN 9000 | MQB | 2007-07-16 | 214 |
Recalls
openFDA lists no recalls under a recalling firm named New Medical Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under New Medical Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “New Medical Co., Ltd.” (first 2007, latest 2012), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by New Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New Medical Co., Ltd. is 58 days.
Which FDA product codes appear under New Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 6).
Next steps
- See all 6 New Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQB, New Medical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.