Cleared Traditional

K173259 - Case Medical SteriTite Reusable Rigid S...

K173259 is an FDA 510(k) clearance for Case Medical SteriTite Reusable Rigid S..., manufactured by Case Medical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K173259 · Case Medical, Inc. · General Hospital
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Jun 2018
Decision
246d
Days
Class 2
Risk

K173259 is an FDA 510(k) clearance for the Case Medical SteriTite Reusable Rigid Sterilization Container System with Med.... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Case Medical, Inc. (South Hackensack, US). The FDA issued a Cleared decision on June 13, 2018 after a review of 246 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 Case Medical, Inc. devices

FDA 510(k) Submission Details - K173259

510(k) Number K173259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2017
Decision Date June 13, 2018
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
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 172
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K173259.
PureSet Tray
K181075 · Nobel Biocare AB · Sep 2018
Sonicision Reusable Sterilization Tray
K180915 · Covidien · Jul 2018
Straumann BLX Surgical Cassette
K180791 · Institut Straumann AG · Jun 2018
OsteoMed QuickFix Hybrid MMF Sterilization Tray
K173391 · Osteomed, LLC · May 2018
Stryker Universal Select Sterilization Tray System
K173615 · Paragon Medical · Apr 2018
Neodent Instrument Kits
K171713 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2018