Unimed Medical Supplies, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Unimed Medical Supplies, Inc.” (first 2008, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 147 days, against 200 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 | 2 | 52 |
| 2013 | 0 | — |
| 2014 | 1 | 61 |
| 2015 | 1 | 129 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 59 |
| 2022 | 1 | 147 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 8 | 164 |
| 2026 | 3 | 29 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Unimed Medical Supplies, Inc. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 200 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 11 | 11 |
| DXQ | Blood Pressure Cuff | 4 | 4 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (12)
- Cardiovascular (6)
- General Hospital (2)
Most recent Unimed Medical Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | FLL | 2026-06-05 | 252 |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | DQA | 2026-04-14 | 25 |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | DXQ | 2026-01-09 | 29 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | DQA | 2025-12-01 | 182 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | DQA | 2025-12-01 | 182 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | DQA | 2025-11-18 | 169 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | DQA | 2025-11-18 | 169 |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | DQA | 2025-08-13 | 138 |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | DXQ | 2025-07-15 | 103 |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | DQA | 2025-02-20 | 143 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Unimed Medical Supplies, Inc..
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.
- Unimed Surgical Products, Inc. (13 510(k)s)
- Unimed Hospital Supply Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unimed Medical Supplies, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Unimed Medical Supplies, Inc.” (first 2008, latest 2026), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Unimed Medical Supplies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unimed Medical Supplies, Inc. is 116 days. Since 2017: 147 days, versus 200 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Unimed Medical Supplies, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 11); DXQ (Blood Pressure Cuff, 4); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2).
Next steps
- See all 20 Unimed Medical Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Unimed Medical Supplies, Inc.'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.