# Reynolds Medical, Ltd.

- Location (FDA's records): Hasbrouck, NJ
- FDA decisions: 12 (1982–2003): 12 510(k) clearances
- Product codes: DSH (4), DXH (3), DPS (2), DSI (1), MWJ (1), DQK (1)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 19 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Agilent Technologies, Inc.: 1 (https://510kreport.com/company/agilent-technologies)
- H&C Medical Devices Spa: 1 (https://510kreport.com/company/h-c-medical-devices)
- General Electric Medical Systems Information Techn: 1 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Spacelabs Burdick, Inc.: 1 (https://510kreport.com/company/spacelabs-burdick)
- Tz Medical, Inc.: 1 (https://510kreport.com/company/tz-medical)
- Paceart, Inc.: 1 (https://510kreport.com/company/paceart)

## Firms that cite its devices most
- Spacelabs Healthcare: 3 (https://510kreport.com/company/spacelabs-healthcare)
- Del Mar Reynolds Medical, Ltd.: 2 (https://510kreport.com/company/del-mar-reynolds-medical)
- Energy-Lab Technologies GmbH: 2 (https://510kreport.com/company/energy-lab-technologies)
- Nexan Telemed, Ltd.: 2 (https://510kreport.com/company/nexan-telemed)
- Platinum Team Co., Ltd.: 1 (https://510kreport.com/company/platinum-team)
- Shl Telemedicine International, Ltd.: 1 (https://510kreport.com/company/shl-telemedicine-international)
- Cardiac Science Corporation: 1 (https://510kreport.com/company/cardiac-science)
- Micro-Star International Co., Ltd.: 1 (https://510kreport.com/company/micro-star-international)

## Its most-cited devices
- K013367: Cardiocollect Portable Electrocardiograph (2001), cited by 3
- K001025: Lifecard CF Compact Recorder (2000), cited by 3
- K024283: Cardiodirect, Models 12M, 12I, 12S (2003), cited by 3
- K951902: Pathfinder 700 Holter Analyzer (1996), cited by 3
- K011837: Lifecard CF 7 Day (2001), cited by 2
- K972649: Cardiocall Cardiac Event Recorder (1997), cited by 2

## Recent decisions
- K024283: Cardiodirect, Models 12M, 12I, 12S (Aug 1, 2003)
- K013367: Cardiocollect Portable Electrocardiograph (Dec 13, 2001)
- K011345: Cardionavigator Information Management System (Jul 20, 2001)
- K011837: Lifecard CF 7 Day (Jul 13, 2001)
- K001025: Lifecard CF Compact Recorder (Apr 19, 2000)
- K991211: Eventstation Ecg Trans-Telephonic Receiving System (Jul 8, 1999)
- K972649: Cardiocall Cardiac Event Recorder (Dec 4, 1997)
- K951902: Pathfinder 700 Holter Analyzer (Jul 15, 1996)

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