Cleared Traditional

K964256 - CYGNUS INSTRUMENT PROTECTORS

K964256 is an FDA 510(k) clearance for CYGNUS INSTRUMENT PROTECTORS, manufactured by Madison Polymeric Engineering. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K964256 · Madison Polymeric Engineering · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
193d
Days
Class 2
Risk

K964256 is an FDA 510(k) clearance for the CYGNUS INSTRUMENT PROTECTORS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Madison Polymeric Engineering (Wallingford, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 193 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 Madison Polymeric Engineering devices

FDA 510(k) Submission Details - K964256

510(k) Number K964256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date May 06, 1997
Days to Decision 193 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
64d slower than avg
Panel avg: 129d · This submission: 193d
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 188
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K964256.
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
CARR RIGID CONTAINER SYSTEM
K972138 · Carr Metal Products, Inc. · Nov 1997
SECURE-WRAP (TM) STERILIZATION WRAP
K971483 · American Threshold Industries, Inc. · Jun 1997
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
K962605 · Surgicot, Inc. · Mar 1997
BIOPSY TRAY
K970152 · Medcare Medical Group, Inc. · Mar 1997
CPR DRESSING CHANGE TRAY
K960206 · Custom Pack Reliability · Apr 1996