Cleared Special

Sturdy Autoclave Super Microm (K231489) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231489 · Sturdy Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
29d
Days
Class 2
Risk

K231489 is an FDA 510(k) clearance for the Sturdy Autoclave Super Microm. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sturdy Industrial Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on June 21, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sturdy Industrial Co., Ltd. devices

Submission Details

510(k) Number K231489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2023
Decision Date June 21, 2023
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 61
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K231489.
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PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · Primus Sterilizer Company, LLC · Feb 2023
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
K213545 · Steelco S.P.A. · Feb 2023