# Midmark Corp.

- Location (FDA's records): Versailles, OH
- FDA decisions: 39 (1981–2026): 39 510(k) clearances
- Names in FDA's records: Midmark Corp. (31); Midmark Corporation (6); Midmark (2)
- Product codes: FLE (9), LGX (4), EIA (3), ETF (3), MUH (3), MWI (2), FPO (2), FQO (2), GBB (1), FMF (1), GDC (1), INQ (1)
- 510(k) review time since 2016: median 159 days, against 178 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 26 (10 its own); citations of its devices by later devices: 20 (10 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Scican, Ltd.: 2 (https://510kreport.com/company/scican)
- Planmeca Oy: 2 (https://510kreport.com/company/planmeca)
- Midmark Diagnostics Group: 1 (https://510kreport.com/company/midmark-diagnostics-group)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Exergen Corp.: 1 (https://510kreport.com/company/exergen)
- Instrumentarium Corp.: 1 (https://510kreport.com/company/instrumentarium)

## Firms that cite its devices most
- Prestige Medical Corp.: 1 (https://510kreport.com/company/prestige-medical)
- Scican, Ltd.: 1 (https://510kreport.com/company/scican)
- Dental X Srl: 1 (https://510kreport.com/company/dental-x)
- Pelton & Crane Co.: 1 (https://510kreport.com/company/pelton-crane)
- Martin Manufacturing Co., LLC: 1 (https://510kreport.com/company/martin-manufacturing)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Mediline Italia S.R.L.: 1 (https://510kreport.com/company/mediline-italia)
- M.O. Com S.R.L.: 1 (https://510kreport.com/company/mo-com)

## Its most-cited devices
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer (1999), cited by 5
- K023348: Midmark M9 Ultraclave Steam Sterilizer (2003), cited by 4
- K120239: Elevance (2012), cited by 2
- K936181: Midmark M-11 Ultraclave Steam Sterilizer (1994), cited by 1
- K992744: Midmark M4*9 Easyclave Steam Sterilizer (2000), cited by 1
- K163337: Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (2017), cited by 1

## Recent decisions
- K253196: Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (Jun 12, 2026)
- K251626: Midmark Dental Delivery System (Nov 3, 2025)
- K233026: Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (Apr 4, 2024)
- K201667: Midmark Extraoral Imaging System (EOIS) (Aug 6, 2020)
- K163337: Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (Aug 31, 2017)
- K161909: IQvitals Zone (Nov 17, 2016)
- K122643: Vantage Model V5000, V5100, V5000C, V5100C (Jan 7, 2013)
- K120239: Elevance (Aug 24, 2012)

Source page: https://510kreport.com/company/midmark