510(k) Report

FDA applicant

Midmark Corp.

Versailles, OH39 decisions1981–20267 recalls

FDA records 39 decisions for Midmark Corp. (Versailles, OH) from 1981 to 2026: 39 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and LGX (Table, Examination, Medical, Powered). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 10 of them its own earlier devices. 7 recalls are linked to its devices.

FDA’s records also spell it “Midmark Corporation”, “Midmark”.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Midmark Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 22011: 12012: 12013: 12016: 12017: 12020: 12024: 12025: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2026

2011: 12013: 12014: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Midmark Corp.’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?

  • FLESterilizer, Steam9decisions
  • LGXTable, Examination, Medical, Powered4decisions
  • EIAUnit, Operative Dental3decisions
  • ETFUnit, Examining/Treatment, Ent3decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital3decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions

Also: FPO (2), FQO (2), GBB (1), FMF (1), GDC (1), INQ (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 159 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 178 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 26 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 10 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.

  • K990189Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 19995cite it
  • K023348Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 20034cite it
  • K120239ElevanceMidmark · 20122cite it
  • K936181Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 19941cites it
  • K992744Midmark M4*9 Easyclave Steam SterilizerMidmark Corp. · 20001cites it
  • K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation · 20171cites it

What has FDA decided for it lately?

  • K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026
  • K251626Midmark Dental Delivery SystemMidmark Corporation · 2025
  • K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerMidmark Corporation · 2024
  • K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation · 2020
  • K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation · 2017
  • K161909IQvitals ZoneMidmark Corporation · 20164 recalls
  • K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp. · 20132 recalls
  • K120239ElevanceMidmark · 2012

All 31 as Midmark Corp. →All 6 as Midmark Corporation →All 2 as Midmark →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K161909Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…Aug 21, 2026Class II
  • K161909Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…Aug 21, 2026Class II
  • K161909Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…Aug 21, 2026Class II
  • K161909Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…Aug 21, 2026Class II
  • K122643Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological…Sep 4, 2014Class II
  • K122643The Vantage Digital Panoramic System delivers high-value features standard on every…Sep 20, 2013Class II

Other applicant names beginning “Midmark”

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

Midmark Diagnostics Group 1