Cleared Traditional

K243589 - PAL Sterilization Case (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243589 · Microaire Surgical Instruments, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
212d
Days
Class 2
Risk

K243589 is an FDA 510(k) clearance for the PAL Sterilization Case. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on June 20, 2025 after a review of 212 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Microaire Surgical Instruments, LLC devices

Submission Details

510(k) Number K243589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2024
Decision Date June 20, 2025
Days to Decision 212 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
84d slower than avg
Panel avg: 128d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 276
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K243589.
PUREVUE™ Quick Connect Cannula System Tray
K253791 · DePuy Mitek, Inc. · Feb 2026
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K251614 · Dentsply Sirona, Inc. · Feb 2026
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K251756 · Paragon Implant Mfg., LLC · Nov 2025
Guided DAS Surgical Kit
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Plastic Surgical Kits
K251300 · Dentsply Sirona, Inc. · Jul 2025
Aesculap Aicon® Series Container System
K242762 · Aesculap, Inc. · May 2025