Cleared Traditional

K142937 - Endoscope Sterilization Tray

K142937 is an FDA 510(k) clearance for Endoscope Sterilization Tray, manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K142937 · Intuitive Surgical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
138d
Days
Class 2
Risk

K142937 is an FDA 510(k) clearance for the Endoscope Sterilization Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 24, 2015 after a review of 138 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K142937

510(k) Number K142937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2014
Decision Date February 24, 2015
Days to Decision 138 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
9d slower than avg
Panel avg: 129d · This submission: 138d
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 267
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K142937.
Instru-Safe Instrument Protection System
K150540 · Summit Medical, Inc. · Jun 2015
Instru-Safe Instrument Protection System
K142768 · Summit Medical, Inc. · May 2015
InterActive Complete Surgical Tray
K142519 · Implant Direct Sybron Manufacturing, LLC · Apr 2015
STERILUCENT STERILIZATION CONTAINER SYSTEM
K142109 · Sterilucent, Inc. · Jan 2015
Genesis Reusable Rigid Container System
K142529 · Carefusion 2200, Inc. · Jan 2015
Instru-Safe Instrument Protection System
K142630 · Summit Medical, Inc. · Dec 2014
K142937 · Endoscope Sterilization Tray
Download PDF FDA Summary Intuitive Surgical, I…