Cleared Traditional

K180528 - InstruSafe Sterilization Container

K180528 is the FDA 510(k) clearance for InstruSafe Sterilization Container by Summit Medical, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

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 161
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