510(k) Report

FDA applicant

Welch Allyn Protocol, Inc.

Beaverton, OR7 decisions2001–20075 recalls

FDA records 7 decisions for Welch Allyn Protocol, Inc. (Beaverton, OR) from 2001 to 2007: 7 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 22 predicates, 4 of them its own earlier devices. 5 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Welch Allyn Protocol, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Welch Allyn Protocol, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions
  • MSXSystem, Network And Communication, Physiological Monitors1decision
  • DQAOximeter1decision
  • DSIDetector And Alarm, Arrhythmia1decision

Whose devices does it build on?

Its devices cite 22 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 200113cite it
  • K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 20036cite it
  • K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 20046cite it
  • K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 20025cite it
  • K021681Micropaq, Models 402, 404Welch Allyn Protocol, Inc. · 20023cite it
  • K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc. · 20062cite it

What has FDA decided for it lately?

  • K070204Link to Acuity Clinician NotifierWelch Allyn Protocol, Inc. · 2007
  • K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc. · 20061 recall
  • K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 20043 recalls
  • K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
  • K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 20021 recall
  • K021681Micropaq, Models 402, 404Welch Allyn Protocol, Inc. · 2002
  • K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001

All 7 as Welch Allyn Protocol, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K033378The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These…Nov 21, 2013Class II
  • K053027Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor…Jul 28, 2009
  • K033378Propaq LT vital signs monitor, Model 802LTRNOct 22, 2006
  • K033378Propaq LT vital signs monitor, Model 802LTONOct 22, 2006
  • K022453Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part #…Dec 31, 2003

Other applicant names beginning “Welch”

FDA records each applicant name separately; these may or may not be the same firm.

Welch Allyn, Inc. 112