# Universal Medical, Inc.

- Location (FDA's records): Philadelphia, PA
- FDA decisions: 8 (1995–2008): 8 510(k) clearances
- Product codes: DXH (8)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Card Guard Scientific Survival, Ltd.: 1 (https://510kreport.com/company/card-guard-scientific-survival)

## Firms that cite its devices most
- Medicalgorithmics S.A.: 2 (https://510kreport.com/company/medicalgorithmics)
- Corventis, Inc.: 1 (https://510kreport.com/company/corventis)
- RhythMedix, LLC: 1 (https://510kreport.com/company/rhythmedix)
- North East Monitoring, Inc.: 1 (https://510kreport.com/company/north-east-monitoring)
- Hds Medical, Inc.: 1 (https://510kreport.com/company/hds-medical)
- Mega Electronics, Ltd.: 1 (https://510kreport.com/company/mega-electronics)

## Its most-cited devices
- K071130: Heartrak AF (2008), cited by 4
- K083535: Heartrak Smart Ecat (2008), cited by 2
- K033451: Heartrak Smart at/Heartrak SMART2 (2004), cited by 2
- K960499: Heartrak XL (1996), cited by 2

## Recent decisions
- K083535: Heartrak Smart Ecat (Dec 15, 2008)
- K071130: Heartrak AF (May 14, 2008)
- K033451: Heartrak Smart at/Heartrak SMART2 (Feb 5, 2004)
- K980624: Cardiostation (May 11, 1998)
- K960499: Heartrak XL (Aug 6, 1996)
- K954495: Pacetrak Plus (Apr 22, 1996)
- K943124: Heartrak (May 3, 1995)
- K943123: Pacetrak (May 3, 1995)

Source page: https://510kreport.com/company/universal-medical