Cleared Traditional

K940807 - SEE-THRU SELF SEALING STERILIZATION POUCH

K940807 is an FDA 510(k) clearance for SEE-THRU SELF SEALING STERILIZATION POUCH, manufactured by Asep-Pro, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K940807 · Asep-Pro, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
269d
Days
Class 2
Risk

K940807 is an FDA 510(k) clearance for the SEE-THRU SELF SEALING STERILIZATION POUCH. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Asep-Pro, Inc. (Irvine, US). The FDA issued a Cleared decision on November 18, 1994 after a review of 269 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 Asep-Pro, Inc. devices

FDA 510(k) Submission Details - K940807

510(k) Number K940807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date November 18, 1994
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 129d · This submission: 269d
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 243
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K940807.
RE-BAG MULTI-USE POUCH, LARGE & SMALL
K954185 · Miltex, Inc. · Dec 1995
AUTO SUTURE* STERILIZATION TRAY**
K954090 · United States Surgical, A Division of Tyco Healthc · Nov 1995
STERRAD STERILIZATION POUCH
K951295 · Advanced Sterilization Products · May 1995
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · Medical Dynamics, Inc. · Apr 1989