Cleared Traditional

K183402 - PRO-LITE Sterilization Tray

K183402 is the FDA 510(k) clearance for PRO-LITE Sterilization Tray by STERIS Corporation. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K183402 · STERIS Corporation · General Hospital
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Mar 2019
Decision
84d
Days
Class 2
Risk

K183402 is an FDA 510(k) clearance for the PRO-LITE Sterilization Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 1, 2019 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all STERIS Corporation devices

Submission Details

510(k) Number K183402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2018
Decision Date March 01, 2019
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K183402.
Neodent Instruments Kits
K182865 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · May 2019
Stryker ChestShield Sterilization Tray System
K183701 · Paragon Medical · May 2019
TCAT (R) THA Instrument Tray Set
K180127 · THINK Surgical, Inc. · Mar 2019
Omni Instrument Tray
K182052 · Hologic, Inc. · Feb 2019
Endoscope Sterilization Tray
K183139 · Intuitive Surgical, Inc. · Feb 2019
PRO-LITE Sterilization Tray
K183301 · STERIS Corporation · Jan 2019