# Paceart, Inc.

- Location (FDA's records): Wayne, NJ
- FDA decisions: 9 (1987–2001): 9 510(k) clearances
- Product codes: DXH (6), KRE (2), DRX (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 12 (2 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
- Tz Medical, Inc.: 2 (https://510kreport.com/company/tz-medical)
- Zymed Medical Instrumentation: 1 (https://510kreport.com/company/zymed-medical-instrumentation)
- Totemite Medical Electronics: 1 (https://510kreport.com/company/totemite-medical-electronics)

## Firms that cite its devices most
- Blakbag, Ltd., Division of Coherent Systems: 3 (https://510kreport.com/company/blakbag-division-of-coherent-systems)
- Heartbeam, Inc.: 1 (https://510kreport.com/company/heartbeam)
- Rozinn Electronics, Inc.: 1 (https://510kreport.com/company/rozinn-electronics)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Cygnus, LLC: 1 (https://510kreport.com/company/cygnus)
- Cybernet Medical: 1 (https://510kreport.com/company/cybernet-medical)
- Harley Street Software, Ltd.: 1 (https://510kreport.com/company/harley-street-software)
- Reynolds Medical, Ltd.: 1 (https://510kreport.com/company/reynolds-medical)

## Its most-cited devices
- K915632: Paceart CPTS-86/12 (1992), cited by 4
- K952065: Paceart Cardiovoice (1996), cited by 3
- K982090: Paceart Home Trak Plus Easi Event Recorder System (1999), cited by 2
- K880283: Paceart Pacemaker Patient Test Syst/Tel Opt CPTS (1988), cited by 1
- K931296: Paceart Cardiophone (1993), cited by 1
- K973141: Heart Access Plus Cardiac Event Recorder (1997), cited by 1

## Recent decisions
- K012407: Paceart TX3 Cardiac Event Recorder (Aug 14, 2001)
- K982090: Paceart Home Trak Plus Easi Event Recorder System (Jan 26, 1999)
- K973141: Heart Access Plus Cardiac Event Recorder (Nov 12, 1997)
- K960721: Paceart Wrist Electrodes (Jul 18, 1996)
- K952065: Paceart Cardiovoice (Jan 16, 1996)
- K931296: Paceart Cardiophone (Oct 1, 1993)
- K915632: Paceart CPTS-86/12 (Apr 14, 1992)
- K880283: Paceart Pacemaker Patient Test Syst/Tel Opt CPTS (Mar 9, 1988)

Source page: https://510kreport.com/company/paceart