510(k) Report

510(k) · Cleared

Cleared

Aegis Ambulatory Monitoring System

K843503510(k) TraditionalCleared Oct 26, 198450-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aegis Medical Systems, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Oct 26, 1984 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Oct 26, 1984
Review
50 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2007: 1 descendant cleared2010: 4 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2011: 4 descendants cleared2016: 4 descendants cleared2015: 3 descendants cleared2014: 2 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant cleared19801990200020102020
  1. This deviceK843503 Aegis Ambulatory Monitoring SystemAegis Medical Systems, Inc. · 1984
  2. Descendant · cites it directly · 26 of its ownK982803 Heartlink, Model IICardiac Telecom Corp. · 1998
  3. Descendant · 2 generations on · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
  4. Descendant · 3 generations on · 18 of its ownK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
  5. Descendant · 4 generations on · 7 of its ownK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
  6. Descendant · 3 generations on · 7 of its ownK090037 Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector…Medicalgorithmics SP Z.O.O. · 2009

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1998: 12007: 12008: 12009: 12010: 42011: 42014: 22015: 32016: 42017: 12023: 22025: 12026: 2
1998high 4 (2010) · low 0 (1999)2026

Most influential descendants

Showing 5 of 27 · See all
  • K982803Heartlink, Model IICardiac Telecom Corp. · 1998 · cites it directly26descendants
  • K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · 2 generations on25descendants
  • K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · 3 generations on18descendants
  • K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010 · 4 generations on7descendants
  • K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O. · 2009 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843503Aegis Ambulatory Monitoring SystemAegis Medical Systems, Inc.1984—
+1K982803Heartlink, Model IICardiac Telecom Corp.1998—
+2K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.20072
+3K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd.20082
+4K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.2010—
+3K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200710
200810
200910
201040
201140
201420
201530
201640
201710
202320
202510
202620
FIG. 1 — Lineage of K843503, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982803Heartlink, Model IICardiac Telecom Corp.199826

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K982803 (Cardiac Telecom Corp., 1998) has gone furthest, with 26 descendants of its own.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K843503 · printed Nov 5, 2026

Cite this page

510(k) Report. “K843503: Aegis Ambulatory Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K843503

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026