510(k) Report

510(k) · Cleared

Cleared

Agilent M2636B Telemon B Monitor (Telemon B)

K011824510(k) SpecialCleared Jul 2, 200121-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

Agilent Technologies, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Jul 2, 2001 as substantially equivalent to K001436 (Agilent Technologies, Inc., 2000) and 7 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1989.

Decided
Jul 2, 2001
Review
21 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K894277 (1989). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestors1999: 1 other ancestor1998: 3 other ancestors1997: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1991: 2 other ancestorsK894277 · M1400A Transmitter,M1402 Receiver,M1401 Mainframe · Hewlett-Packard Co. · 1989K980429 · HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry System) · Hewlett-Packard Co. · 1998K993516 · HP M2600A Viridia Telemetry System · Hewlett-Packard Co. · 19991985199019952000
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 4 other ancestors K993516 · HP M2600A Viridia Telemetry System · Hewlett-Packard Co. · 1999K980429 · HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry System) · Hewlett-Packard Co. · 1998K894277 · M1400A Transmitter,M1402 Receiver,M1401 Mainframe · Hewlett-Packard Co. · 19890
  1. Root · 3 generations backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
  2. 2 generations backK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
  3. 1 generation backK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
  4. This deviceK011824 Agilent M2636B Telemon B Monitor (Telemon B)Agilent Technologies, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K894277M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co.1989—
−2K980429HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care…Hewlett-Packard Co.1998—
−1K993516HP M2600A Viridia Telemetry SystemHewlett-Packard Co.1999—
0 (this device)K011824Agilent M2636B Telemon B Monitor (Telemon B)Agilent Technologies, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199310
199410
199710
199830
199910
200020
FIG. 1 — Lineage of K011824, 1989–2001Source: 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), the FDA summary (predicates and indications), 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? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001436Agilent M2636A Telemon Monitor
Summary page 3
…is substantially equivalent to the previously cleared devices listed below: Manufacturer Device Model 510(k) Agilent Technologies, Inc. | M2636A TeleMon Monitor M2636A K001436 Hewlett Packard/Agilent Viridia Information Center Software for M315x, K000854 Technologies M3150A and M3153A, and Viridia Teleme…
Agilent Technologies, Inc.2000—
*K000854Viridia Information Center Software for M3150A and M3153A, Viridia Telemetry System…
Summary page 2
…00A Telemetry System and Viridia/Agilent Information System, and remains compliant. These components were previously cleared for commercial use in Premarket Notification K000854 (cleared April 3, 2000), K993516 (cleared November 8, 1999), K980429 (cleared September 9,1998), and K991773 (cleared June 7, 199…
Agilent Technologies, Inc.2000—
*K993516HP M2600A Viridia Telemetry System
Summary page 2
…Agilent Information System, and remains compliant. These components were previously cleared for commercial use in Premarket Notification K000854 (cleared April 3, 2000), K993516 (cleared November 8, 1999), K980429 (cleared September 9,1998), and K991773 (cleared June 7, 1999). Agilent Technologies June 8,…
Hewlett-Packard Co.1999—
*K991773HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…
Summary page 2
…viously cleared for commercial use in Premarket Notification K000854 (cleared April 3, 2000), K993516 (cleared November 8, 1999), K980429 (cleared September 9,1998), and K991773 (cleared June 7, 1999). Agilent Technologies June 8, 2001 -67 - § Kollg24 p.3/y Confidential 11.8 Substantial…
Hewlett-Packard GmbH1999—
*K981576Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A
Summary page 3
…es ‘ ' Hewlett Packard/Agilent Viridia HP M3000A/M3046A (M3/M4) M3000A K991773 Technologies M3046A Hewlett Packard/Agilent HP Models M3000A/M3046A Patient Monitor M3000A K981576 Technologies M3046A Hewlett Packard/Agilent Viridia Wave Viewer M2605A K974567 Technologies Hewlett Packard/Agilent Detector and…
Hewlett-Packard GmbH1998—
*K974567Hewlett-Packard M2605A Viridia Wave Viewer
Summary page 3
…Technologies M3046A Hewlett Packard/Agilent HP Models M3000A/M3046A Patient Monitor M3000A K981576 Technologies M3046A Hewlett Packard/Agilent Viridia Wave Viewer M2605A K974567 Technologies Hewlett Packard/Agilent Detector and Alarm, Arrhythmia (see M315x, K964122 Technologies M30xx, M2600) Hewlett Packar…
Hewlett-Packard Co.1998—
*K964122HP Star ST and Arrhhythmia Software
Summary page 3
…0A K981576 Technologies M3046A Hewlett Packard/Agilent Viridia Wave Viewer M2605A K974567 Technologies Hewlett Packard/Agilent Detector and Alarm, Arrhythmia (see M315x, K964122 Technologies M30xx, M2600) Hewlett Packard/Agilent HP M1175A, M1176A Component Monitoring | MI175A, K941811 Technologies System _…
Hewlett-Packard Co.1997—
*K941811HP M1175A, M1176A, Component Monitoring System
Summary page 3
…tt Packard/Agilent Detector and Alarm, Arrhythmia (see M315x, K964122 Technologies M30xx, M2600) Hewlett Packard/Agilent HP M1175A, M1176A Component Monitoring | MI175A, K941811 Technologies System _ MI1176A 11.9 Modification Description The modification in this submission is the addition of audible alar…
Hewlett-Packard Co.1994—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • None of the 14 ancestors has a recall.

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—

What is it indicated for?

TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Agilent Technologies, Inc.

105 FDA decisions under this applicant name. See the company

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  • P150013/S034PD-L1 IHC 22C3 pharmDxAgilent Technologies, Inc. · 2026
  • P150025/S019PD-L1 IHC 28-8 pharmDxAgilent Technologies, Inc. · 2026
  • P230016/S003MAGE-A4 IHC 1F9 pharmDxAgilent Technologies, Inc. · 2026
  • P150025/S020PD-L1 IHC 28-8 pharmDxAgilent Technologies, Inc. · 2026

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/K011824 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011824: Agilent M2636B Telemon B Monitor (Telemon B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011824

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026