# iRhythm Technologies, Inc.

- Location (FDA's records): San Francisco, CA
- FDA decisions: 18 (2008–2026): 18 510(k) clearances
- Product codes: DQK (8), DSH (6), QYX (2), DXH (1), DSI (1)
- 510(k) review time since 2016: median 262 days, against 151 for FDA's reviews in the same codes and years (1 of 10 faster)
- Predicates its devices cite: 19 (14 its own); citations of its devices by later devices: 29 (14 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rozinn Electronics, Inc.: 1 (https://510kreport.com/company/rozinn-electronics)
- Monebo Technologies, Inc.: 1 (https://510kreport.com/company/monebo-technologies)
- Corventis, Inc.: 1 (https://510kreport.com/company/corventis)
- Verily Life Sciences, LLC: 1 (https://510kreport.com/company/verily-life-sciences)
- Epi Mobile Health Solutions (S) Pte, Ltd.: 1 (https://510kreport.com/company/epi-mobile-health-solutions-s)

## Firms that cite its devices most
- RhythMedix, LLC: 1 (https://510kreport.com/company/rhythmedix)
- Atsens Co., Ltd.: 1 (https://510kreport.com/company/atsens)
- Cardiac Science Corporation: 1 (https://510kreport.com/company/cardiac-science)
- Cardiac Insight, Inc.: 1 (https://510kreport.com/company/cardiac-insight)
- Dms-Service, LLC: 1 (https://510kreport.com/company/dms-service)
- Quanta Computer, Inc.: 1 (https://510kreport.com/company/quanta-computer)
- Qardio, Inc.: 1 (https://510kreport.com/company/qardio)
- Peerbridge Health, Inc.: 1 (https://510kreport.com/company/peerbridge-health)

## Its most-cited devices
- K143513: ZIO SR ECG Monitoring Service (2015), cited by 9
- K163512: Zio AT ECG Monitoring System (2017), cited by 4
- K121319: Zio Patch (2012), cited by 3
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), cited by 2
- K202527: Zio ECG Utilization Software (ZEUS) System (2021), cited by 2
- K202359: Zio Monitor (2021), cited by 2

## Recent decisions
- K252859: ZEUS Platform (FG0501US) (May 29, 2026)
- K243650: Zio® monitor  (DFG0001) (Aug 15, 2025)
- K240177: Zio AT® device (A100A1001) (Oct 30, 2024)
- K240029: Zio AT® device (A100A1001) (Oct 21, 2024)
- K222389: ZEUS System (Feb 15, 2023)
- K213409: ZEUS System (Zio Watch) (Jul 19, 2022)
- K202527: Zio ECG Utilization Software (ZEUS) System (May 21, 2021)
- K202359: Zio Monitor (May 21, 2021)

Source page: https://510kreport.com/company/irhythm-technologies