Cleared Traditional

K233026 - Midmark Smart M9 Sterilizer

K233026 is an FDA 510(k) clearance for Midmark Smart M9 Sterilizer, manufactured by Midmark Corporation. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K233026 · Midmark Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2024
Decision
195d
Days
Class 2
Risk

K233026 is an FDA 510(k) clearance for the Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Midmark Corporation (Versailles, US). The FDA issued a Cleared decision on April 4, 2024 after a review of 195 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Midmark Corporation devices

FDA 510(k) Submission Details - K233026

510(k) Number K233026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date April 04, 2024
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 75
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K233026.
Cassette Autoclave (ACA5)
K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · Aug 2025
Steam Sterilizer (2545D)
K243994 · Ningbo Ican Machines Co., Ltd. · Jun 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · Fort Defiance Industries, LLC · Mar 2025
Lexa MINI (RIS-303, RIS-305)
K233504 · W&H Sterilization S.R.L. · Feb 2024
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · Primus Sterilizer Company, LLC · Dec 2023
T-Top 10 & T-Top T-Top 11
K232658 · Tuttnauer U.S.A Co, Ltd. · Nov 2023