510(k) Report

FDA applicant

iRhythm Technologies, Inc.

San Francisco, CA18 decisions2008–20261 recall

FDA records 18 decisions for iRhythm Technologies, Inc. (San Francisco, CA) from 2008 to 2026: 18 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DSH (Recorder, Magnetic Tape, Medical). Since 2016 its 510(k)s took a median of 262 days from receipt to decision, against 151 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 14 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided iRhythm Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12009: 22012: 22014: 12015: 12017: 12018: 12019: 12021: 22022: 12023: 12024: 22025: 12026 (partial year): 1
2008high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2008high 1 (2022) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — iRhythm Technologies, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like iRhythm Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable8decisions
  • DSHRecorder, Magnetic Tape, Medical6decisions
  • QYXOutpatient Cardiac Telemetry2decisions
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • DSIDetector And Alarm, Arrhythmia1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 262 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 151 days; 1 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 20159cite it
  • K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 20174cite it
  • K121319Zio PatchiRhythm Technologies, Inc. · 20123cite it
  • K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 20182cite it
  • K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc. · 20212cite it
  • K202359Zio MonitoriRhythm Technologies, Inc. · 20212cite it

What has FDA decided for it lately?

  • K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc. · 2026
  • K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K222389ZEUS SystemiRhythm Technologies, Inc. · 2023
  • K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc. · 2022
  • K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc. · 2021
  • K202359Zio MonitoriRhythm Technologies, Inc. · 2021

All 18 as iRhythm Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K163512Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information…Sep 28, 2022Class II