Uzinmedicare Co.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Uzinmedicare Co.” (first 2010, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 271 days. Since 2017 the median was 256 days, against 151 days for all cleared 510(k)s in the same product codes. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 416 |
| 2017 | 0 | — |
| 2018 | 1 | 150 |
| 2019 | 1 | 158 |
| 2020 | 1 | 271 |
| 2021 | 1 | 273 |
| 2022 | 1 | 256 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 154 |
| 2026 | 3 | 274 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Uzinmedicare Co. took a median 256 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 11 | 11 |
Review panels
Most recent Uzinmedicare Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260956 | Spectra Platinum Mini | HGX | 2026-06-04 | 73 |
| K250208 | SPECTRA Wearable 2 | HGX | 2026-04-06 | 437 |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | HGX | 2026-02-06 | 274 |
| K251932 | Spectra Platinum | HGX | 2025-11-25 | 154 |
| K220926 | Spectra Wearable | HGX | 2022-12-12 | 256 |
| K210124 | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | HGX | 2021-10-19 | 273 |
| K191109 | Spectra Q | HGX | 2020-01-22 | 271 |
| K191208 | Spectra Cashmere | HGX | 2019-10-11 | 158 |
| K181784 | Spectra S3 Plus | HGX | 2018-11-30 | 150 |
| K150476 | Spectra S1Plus and Spectra S2 Plus | HGX | 2016-04-15 | 416 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Uzinmedicare Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Uzinmedicare Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Uzinmedicare Co.?
FDA lists 11 510(k) clearances under the applicant name “Uzinmedicare Co.” (first 2010, latest 2026), 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 Uzinmedicare Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Uzinmedicare Co. is 271 days. Since 2017: 256 days, versus 151 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Uzinmedicare Co.?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 11).
Next steps
- See all 11 Uzinmedicare Co. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Uzinmedicare Co.'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.