510(k) Report

510(k) · Cleared

Cleared

Zymed Telemetry System; Model T8010

K951370510(k) TraditionalCleared Oct 6, 1995193-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

Zymed Medical Instrumentation · DSI Detector And Alarm, Arrhythmia

Cleared on Oct 6, 1995 after a 193-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 442 later devices descend from it.

Decided
Oct 6, 1995
Review
193 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

442 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 4 descendants cleared1998: 1 descendant cleared2001: 2 descendants cleared2004: 10 descendants cleared2003: 8 descendants cleared2002: 4 descendants cleared2006: 17 descendants cleared2010: 21 descendants cleared2011: 21 descendants cleared2007: 7 descendants cleared2012: 19 descendants cleared2009: 19 descendants cleared2008: 14 descendants cleared2005: 10 descendants cleared2013: 17 descendants cleared2015: 14 descendants cleared2018: 25 descendants cleared2016: 17 descendants cleared2014: 16 descendants cleared2017: 17 descendants cleared2021: 19 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2022: 28 descendants cleared2023: 27 descendants cleared2020: 14 descendants cleared2024: 25 descendants cleared2019: 17 descendants cleared1995200020052010201520202025
  1. This deviceK951370 Zymed Telemetry System; Model T8010Zymed Medical Instrumentation · 1995
  2. Descendant · cites it directly · 437 of its ownK990476 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model…Hewlett-Packard GmbH · 1999
  3. Descendant · 2 generations on · 436 of its ownK992595 HP Viridia Component Monitoring System, Model Rev. K with Easi-ST…Hewlett-Packard GmbH · 1999
  4. Descendant · 2 generations on · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  5. Descendant · 3 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  6. Descendant · 3 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002

Showing 5 of 442 descendants. See all descendants

Descendants cleared per year

1998: 11999: 42001: 22002: 42003: 82004: 102005: 102006: 172007: 72008: 142009: 192010: 212011: 212012: 192013: 172014: 162015: 142016: 172017: 172018: 252019: 172020: 142021: 192022: 282023: 272024: 252025: 292026: 20
1998high 29 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 442 · See all
  • K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg…Hewlett-Packard GmbH · 1999 · cites it directly437descendants
  • K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…Hewlett-Packard GmbH · 1999 · 2 generations on436descendants
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · 2 generations on431descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 3 generations on421descendants
  • K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 3 generations on416descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951370Zymed Telemetry System; Model T8010Zymed Medical Instrumentation1995—
+1K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K…Hewlett-Packard GmbH1999—
+2K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment…Hewlett-Packard GmbH1999—
+2K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
+3K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+3K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199940
200120
200240
200380
2004100
2005100
2006170
200770
2008140
2009190
2010210
2011210
2012190
2013170
2014160
2015140
2016170
2017170
2018250
2019170
2020140
2021190
2022280
2023270
2024250
2025290
2026200
FIG. 1 — Lineage of K951370, 1995–2026Source: 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (442)

See all 442

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

NumberDeviceApplicantDecidedDescendants
K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg…Hewlett-Packard GmbH1999437
K980186Zymed Telemetry SystemAgilent Technologies19983

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, K990476 (Hewlett-Packard GmbH, 1999) has gone furthest, with 437 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—

More from Zymed Medical Instrumentation

7 FDA decisions under this applicant name. See the company

  • K002004ZYBITZymed Medical Instrumentation · 2000
  • K992197Modification to Zymed Holter 2000Zymed Medical Instrumentation · 1999
  • K990170Holter 2000Zymed Medical Instrumentation · 1999
  • K984089Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 1999
  • K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996

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/K951370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951370: Zymed Telemetry System; Model T8010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951370

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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