510(k) Report

510(k) · Cleared

Cleared

Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options

K951246510(k) TraditionalCleared Feb 2, 1996319-day reviewClass II21 CFR 868.2377

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

Protocol Systems, Inc. · FLS Monitor, Apnea, Facility Use

Cleared on Feb 2, 1996 after a 319-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 431 devices in its family, counting itself, has a Class I recall. 430 later devices descend from it.

Decided
Feb 2, 1996
Review
319 days
Class
Class II
Product code
FLS
Recalls
None
Predicates
0

430 later devices descend from it, 5 citing it directly. 1 of the 431 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2001: 1 descendant cleared2003: 2 descendants cleared1999: 1 descendant cleared2004: 1 descendant cleared2009: 12 descendants cleared2016: 19 descendants cleared2006: 6 descendants cleared2017: 24 descendants cleared2013: 19 descendants cleared2012: 19 descendants cleared2010: 15 descendants cleared, 1 with a Class I recall12008: 11 descendants cleared2007: 6 descendants cleared2005: 3 descendants cleared2011: 21 descendants cleared2014: 23 descendants cleared2015: 22 descendants cleared2020: 24 descendants cleared2019: 24 descendants cleared2021: 12 descendants cleared2022: 28 descendants cleared2023: 29 descendants cleared2018: 24 descendants cleared2025: 36 descendants cleared2024: 27 descendants cleared2026: 20 descendants cleared1995200020052010201520202025
  1. This deviceK951246 Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance…Protocol Systems, Inc. · 1996
  2. Descendant · cites it directly · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
  3. Descendant · cites it directly · 280 of its ownK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
  4. Descendant · 2 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  5. Descendant · 3 generations on · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  6. Descendant · 3 generations on · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008

Showing 5 of 430 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12001: 12003: 22004: 12005: 32006: 62007: 62008: 112009: 122010: 152011: 212012: 192013: 192014: 232015: 222016: 192017: 242018: 242019: 242020: 242021: 122022: 282023: 292024: 272025: 362026: 20
1998high 36 (2025) · low 0 (2000)2026

Class I recalls in this family

  • K093261 MOVES2 generations on · 2010

Most influential descendants

Showing 5 of 430 · See all
  • K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · cites it directly290descendants
  • K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001 · cites it directly280descendants
  • K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on175descendants
  • K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 3 generations on151descendants
  • K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · 3 generations on143descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951246Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography…Protocol Systems, Inc.1996—
+1K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003—
+1K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc.2001—
+2K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+3K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+3K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue…Philips Medizin Systeme Boeblingen GmbH2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
200320
200410
200530
200660
200760
2008110
2009120
2010151
2011210
2012190
2013190
2014230
2015220
2016190
2017240
2018240
2019240
2020240
2021120
2022280
2023290
2024270
2025360
2026200
FIG. 1 — Lineage of K951246, 1996–2026Source: 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • 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? (430)

See all 430

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

NumberDeviceApplicantDecidedDescendants
K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003290
K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc.2001280
K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc.2004108
K980619Sabratek Patient Home Management SystemSabratek Corp.19981
K993643Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd.19990

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K031740 (Welch Allyn Protocol, Inc., 2003) has gone furthest, with 290 descendants of its own.

How does its category compare?

All FLS devices

FLS Monitor, Apnea, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLS

FDA has decided no FLS device since 2007.

Median 510(k) review, days · FLS

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

Recalls per year · FLS

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FLS

1in 2019

2007: 52008: 32009: 62010: 142011: 212012: 132013: 152014: 102015: 122016: 32018: 42019: 1
2007high 21 (2011) · low 0 (2017)2025

MAUDE reports naming product code FLS, 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—15
20080—03
20090—16
20100—014
20110—021
20120—013
20130—015
20140—010
20150—012
20160—03
20170—00
20180—04
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Protocol Systems, Inc.

15 FDA decisions under this applicant name. See the company

  • K002725Micropaq, Models 402 and 404Protocol Systems, Inc. · 2000
  • K972121Acuity Central StationProtocol Systems, Inc. · 1997
  • K945071Propaq 200 MonitorProtocol Systems, Inc. · 1995
  • K935846Model Acuity Central StationProtocol Systems, Inc. · 1994
  • K934711Propaq Ecg Telemetry OptionProtocol Systems, Inc. · 1994

Recent decisions in FLS

The FLS category page

  • K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 20022 recalls
  • K991087Hannah Wireless Vital Signs MonitorIlife Systems, Inc. · 2000
  • K962865Rembrandt SystemAirsep Corp. · 1996
  • K894973Respitrace PlusHogan & Hartson · 1989
  • K832999Respiration MonitorLitton Medical Electronics · 1984

https://510kreport.com/device/K951246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951246: Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951246

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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