Universal Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Universal Medical, Inc.” (first 1995, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 197 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 | 0 | — |
| 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 8 | 8 |
Review panels
- Cardiovascular (8)
Most recent Universal Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083535 | HEARTRAK SMART ECAT | DXH | 2008-12-15 | 17 |
| K071130 | HEARTRAK AF | DXH | 2008-05-14 | 387 |
| K033451 | HEARTRAK SMART AT/HEARTRAK SMART2 | DXH | 2004-02-05 | 98 |
| K980624 | CARDIOSTATION | DXH | 1998-05-11 | 82 |
| K960499 | HEARTRAK XL | DXH | 1996-08-06 | 186 |
| K954495 | PACETRAK PLUS | DXH | 1996-04-22 | 208 |
| K943124 | HEARTRAK | DXH | 1995-05-03 | 308 |
| K943123 | PACETRAK | DXH | 1995-05-03 | 308 |
Recalls
openFDA lists no recalls under a recalling firm named Universal Medical, 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.
- Universal Medical Instrument Corp. (21 510(k)s)
- Universal Reagents, Inc. (8 510(k)s)
- Universal Gloves Corp. (3 510(k)s)
- Universal Prosthetics, Inc. (3 510(k)s)
- Universal Technology Systems, Inc. (3 510(k)s)
- Universal Gym Equipment, Inc. (2 510(k)s)
- Universal Health Care Products Canada, Inc. (2 510(k)s)
- Universal Implant Systems, Inc. (2 510(k)s)
- Universal Instruments Corp. (2 510(k)s)
- Universal Biosensors Pty, Ltd. (1 510(k)s)
- Universal Bodycare (I) Sdn. Bhd. (1 510(k)s)
- Universal Brain (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Universal Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Universal Medical, Inc.” (first 1995, latest 2008), 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 Universal Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Universal Medical, Inc. is 197 days.
Which FDA product codes appear under Universal Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 8).
Next steps
- See all 8 Universal Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Universal Medical, 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.