Cleared Traditional

K243589 - PAL Sterilization Case

K243589 is an FDA 510(k) clearance for PAL Sterilization Case, manufactured by Microaire Surgical Instruments, LLC. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K243589 · Microaire Surgical Instruments, LLC · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K243589

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
83d slower than avg
Panel avg: 129d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

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 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K243589.
Sterilization Trays
K251756 · Paragon Implant Mfg., LLC · Nov 2025
Guided DAS Surgical Kit
K243425 · Talladium Espa?a, SL · Jul 2025
Plastic Surgical Kits
K251300 · Dentsply Sirona, Inc. · Jul 2025
Aesculap Aicon® Series Container System
K242762 · Aesculap, Inc. · May 2025
ONE TRAY® Sealed Sterilization Container System
K250029 · Innovative Sterilization Technologies · May 2025
Synthes Graphic Case & Tray System
K241927 · Synthes GmbH · Mar 2025