Cleared Traditional

K110867 - STERI-DENT, STERI-SURE

K110867 is an FDA 510(k) clearance for STERI-DENT, manufactured by Cpac, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K110867 · Cpac, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
113d
Days
Class 2
Risk

K110867 is an FDA 510(k) clearance for the STERI-DENT, STERI-SURE. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Cpac, Inc. (Leicester, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 113 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 Cpac, Inc. devices

FDA 510(k) Submission Details - K110867

510(k) Number K110867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2011
Decision Date July 20, 2011
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

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 238
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K110867.
DURA BLUE STERILIZATION WRAP
K112211 · Cardinal Health200, LLC · Oct 2011
DURA BLUE STERILIZATION WRAP
K112283 · Cardinal Health200, LLC · Oct 2011
SIGMA STERILIZATION POUCH & ROLL
K102158 · Sigma Medical Supplies Corp. · Aug 2011
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
K103210 · Advanced Sterilization Products · Jun 2011
84E SERIES SINGLE PLY WRAPPER
K102864 · Lac Mac, Ltd. · Jan 2011
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
K102783 · Hinson and Hale Medical Technologies, Inc. · Dec 2010