Cleared Traditional

K183701 - Stryker ChestShield Sterilization Tray ...

K183701 is an FDA 510(k) clearance for Stryker ChestShield Sterilization Tray ..., manufactured by Paragon Medical. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K183701 · Paragon Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
127d
Days
Class 2
Risk

K183701 is an FDA 510(k) clearance for the Stryker ChestShield Sterilization Tray System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Paragon Medical (Pierceton, US). The FDA issued a Cleared decision on May 7, 2019 after a review of 127 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.

View all Paragon Medical devices

FDA 510(k) Submission Details - K183701

510(k) Number K183701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date May 07, 2019
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 174
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K183701.
Sonopet iQ Sterilization Tray
K190667 · Paragon Medical · Jun 2019
DePuy Synthes Sterilization Container System
K181933 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · May 2019
Neodent Instruments Kits
K182865 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · May 2019
TCAT (R) THA Instrument Tray Set
K180127 · THINK Surgical, Inc. · Mar 2019
PRO-LITE Sterilization Tray
K183402 · STERIS Corporation · Mar 2019
Omni Instrument Tray
K182052 · Hologic, Inc. · Feb 2019