510(k) Report

510(k) · Cleared

Cleared

Easi Lead System Cable Assembly

K872781510(k) TraditionalCleared Dec 29, 1987168-day reviewClass II21 CFR 870.2350

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

Totemite Medical Electronics · DRW Adaptor, Lead Switching, Electrocardiograph

Cleared on Dec 29, 1987 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 445 later devices descend from it.

Decided
Dec 29, 1987
Review
168 days
Class
Class II
Product code
DRW
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 3 descendants cleared2025: 31 descendants cleared2002: 5 descendants cleared2001: 1 descendant cleared2004: 11 descendants cleared2003: 8 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 cleared2020: 15 descendants cleared2013: 17 descendants cleared2015: 14 descendants cleared2018: 25 descendants cleared2016: 17 descendants cleared2014: 16 descendants cleared2017: 17 descendants cleared2021: 19 descendants cleared2026: 20 descendants cleared2022: 29 descendants cleared2023: 27 descendants cleared2024: 25 descendants cleared2019: 17 descendants cleared1990200020102020
  1. This deviceK872781 Easi Lead System Cable AssemblyTotemite Medical Electronics · 1987
  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 445 descendants. See all descendants

Descendants cleared per year

1999: 32001: 12002: 52003: 82004: 112005: 102006: 172007: 72008: 142009: 192010: 212011: 212012: 192013: 172014: 162015: 142016: 172017: 172018: 252019: 172020: 152021: 192022: 292023: 272024: 252025: 312026: 20
1999high 31 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 445 · 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)K872781Easi Lead System Cable AssemblyTotemite Medical Electronics1987—
+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
199930
200110
200250
200380
2004110
2005100
2006170
200770
2008140
2009190
2010210
2011210
2012190
2013170
2014160
2015140
2016170
2017170
2018250
2019170
2020150
2021190
2022290
2023270
2024250
2025310
2026200
FIG. 1 — Lineage of K872781, 1987–2026Source: 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.

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  • Recall history across each candidate’s familyin 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? (445)

See all 445

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
K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.19996

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 DRW devices

DRW Adaptor, Lead Switching, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRW

FDA has decided no DRW device since 2007.

Median 510(k) review, days · DRW

Too few DRW 510(k)s in any year since 2007 to give a median.

Recalls per year · DRW

No recall names DRW since 2007.

Adverse event reports per year · DRW

1in 2017

2016: 22017: 1
2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code DRW, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—02
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Totemite Medical Electronics

2 FDA decisions under this applicant name. See the company

  • K802900Heart SentinelTotemite Medical Electronics · 1981

Recent decisions in DRW

The DRW category page

  • K033513Easi Ecg AlgorithmPhilips Medical Systems · 2004
  • K020456Easi 12 Lead AlgorithmPhilips Medical Systems · 2002
  • K930786EPCORSiemens Medical Solutions USA, Inc. · 1994
  • K861981Electrocardiograph Lead Switching AdaptorVital Signs, Inc. · 1986
  • K851627KBX-20 Outboard Keyboard Access. for G-2000 ElectrEaton Medical Group · 1985

https://510kreport.com/device/K872781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872781: Easi Lead System Cable Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872781

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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