Cleared Traditional

K180528 - InstruSafe(R) Sterilization Container

K180528 is an FDA 510(k) clearance for InstruSafe Sterilization Container, manufactured by Summit Medical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K180528 · Summit Medical, Inc. · General Hospital
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Nov 2018
Decision
261d
Days
Class 2
Risk

K180528 is an FDA 510(k) clearance for the InstruSafe(R) Sterilization Container. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Summit Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 16, 2018 after a review of 261 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 Summit Medical, Inc. devices

FDA 510(k) Submission Details - K180528

510(k) Number K180528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2018
Decision Date November 16, 2018
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
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 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K180528.
Endoscope Sterilization Tray
K183139 · Intuitive Surgical, Inc. · Feb 2019
PRO-LITE Sterilization Tray
K183301 · STERIS Corporation · Jan 2019
SterilContainer S System
K182032 · Aesculap, Inc. · Dec 2018
KLOCKNER SURGICAL BOX
K173642 · SOADCO, S.L. · Oct 2018
Endoscope Sterilization Tray
K180964 · Intuitive Surgical, Inc. · Sep 2018
PureSet Tray
K181075 · Nobel Biocare AB · Sep 2018