510(k) Report

510(k) · Cleared

Cleared

Century Color Trace

K884152510(k) TraditionalCleared Dec 15, 198873-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

Biomedical Systems, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Dec 15, 1988 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.

Decided
Dec 15, 1988
Review
73 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

48 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 2 descendants cleared2006: 2 descendants cleared2009: 1 descendant cleared2015: 4 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2016: 2 descendants cleared2017: 3 descendants cleared2022: 4 descendants cleared2020: 1 descendant cleared2018: 2 descendants cleared2023: 3 descendants cleared2024: 6 descendants cleared2026: 7 descendants cleared2025: 5 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK884152 Century Color TraceBiomedical Systems, Inc. · 1988
  2. Descendant · cites it directly · 35 of its ownK042463 Holter PlusRozinn Electronics, Inc. · 2004
  3. Descendant · 2 generations on · 32 of its ownK091075 Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009
  4. Descendant · 3 generations on · 31 of its ownK142681 ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014
  5. Descendant · 4 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
  6. Descendant · 5 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22006: 22009: 12010: 12014: 22015: 42016: 22017: 32018: 22019: 12020: 12021: 12022: 42023: 32024: 62025: 52026: 7
2003high 7 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 48 · See all
  • K042463Holter PlusRozinn Electronics, Inc. · 2004 · cites it directly35descendants
  • K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009 · 2 generations on32descendants
  • K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014 · 3 generations on31descendants
  • K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 4 generations on30descendants
  • K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 5 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884152Century Color TraceBiomedical Systems, Inc.1988—
+1K042463Holter PlusRozinn Electronics, Inc.2004—
+2K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc.2009—
+3K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc.2014—
+4K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.2015—
+5K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200620
200910
201010
201420
201540
201620
201730
201820
201910
202010
202110
202240
202330
202460
202550
202670
FIG. 1 — Lineage of K884152, 1988–2026Source: 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? (48)

See all 48

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042463Holter PlusRozinn Electronics, Inc.200435
K024323Century Series Holter Scanner System, Models C3000, C2000 and C1000Biomedical Systems Corp.20039
K042799QRS-Card Cardiology SuitePulse Biomedical, Inc.20041

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, K042463 (Rozinn Electronics, Inc., 2004) has gone furthest, with 35 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/K884152 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884152: Century Color Trace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884152

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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