510(k) Report

FDA applicant

Mortara Instrument, Inc.

Milwaukee, WI51 decisions1983–201922 recalls

FDA records 51 decisions for Mortara Instrument, Inc. (Milwaukee, WI) from 1983 to 2019: 51 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 61 predicates, 41 of them its own earlier devices. 22 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 Mortara Instrument, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 12008: 22009: 12010: 42011: 12012: 22013: 22014: 42016: 42017: 12018: 12019: 1
2007high 4 (2010) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

5in 2024

2014: 12015: 12020: 82021: 42022: 12023: 22024: 5
2007high 8 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mortara Instrument, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DPSElectrocardiograph21decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)7decisions
  • LOSUnnamed device6decisions
  • MWJElectrocardiograph, Ambulatory (Without Analysis)3decisions
  • DSIDetector And Alarm, Arrhythmia3decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency3decisions

Also: DSH (2), DRT (1), MLO (1), DQK (1), DXN (1), DXJ (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 150 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 170 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 61 predicates; 41 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 66 times; 41 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.

  • K974149Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 19987cite it
  • K082946Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 20087cite it
  • K031182Eli 200+ AudicorMortara Instrument, Inc. · 20035cite it
  • K021373H12+Holter RecorderMortara Instrument, Inc. · 20024cite it
  • K050896H12+ Holter RecorderMortara Instrument, Inc. · 20052cite it
  • K060135Mortara Surveyor Telemetry Central StationMortara Instrument, Inc. · 20062cite it

What has FDA decided for it lately?

  • K182297Surveyor S2Mortara Instrument, Inc. · 2019
  • K173765Surveyor Patient MonitorMortara Instrument, Inc. · 20182 recalls
  • K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
  • K161465CardioConfirmMortara Instrument, Inc. · 2016
  • K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 20161 recall
  • K152626H3+ Holter RecorderMortara Instrument, Inc. · 2016
  • K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsMortara Instrument, Inc. · 20165 recalls
  • K141020Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2014

All 51 as Mortara Instrument, Inc. →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K120865Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; ElectrocardiographOct 11, 2024Class II
  • K004017Hillrom Welch Allyn HScribe Holter System; ambulatory monitoringOct 11, 2024Class II
  • K152944Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress testOct 11, 2024Class II
  • K004017Hillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographOct 11, 2024Class II
  • K152944Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic…Oct 11, 2024Class II
  • K152944Q-Stress Cardiac Stress Testing System, version 6, with below product name / product…Dec 8, 2023Class II