Cleared Traditional

SteriTite Containers System & MediTray Products (K161415) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161415 · Case Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
263d
Days
Class 2
Risk

K161415 is an FDA 510(k) clearance for the SteriTite Containers System & MediTray Products. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Case Medical, Inc. (South Hackensack, US). The FDA issued a Cleared decision on February 10, 2017 after a review of 263 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

Submission Details

510(k) Number K161415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2016
Decision Date February 10, 2017
Days to Decision 263 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 129d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 90
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K161415.
SIGMA Sterilization Pouch and Roll
K180661 · Sigma Medical Supplies Corp. · Jun 2018
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K172749 · STERIS Corporation · Feb 2018
Gemini Sterilization Wrap
K162993 · Medline Industries, Inc. · Jun 2017
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · STERIS Corporation · Jul 2016
Gemini Sterilization Wrap
K152564 · Medline Industries, Inc. · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016