Cleared Traditional

K932922 - PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR

K932922 is an FDA 510(k) clearance for PROCIDE 14 N.S., manufactured by Cottrell, Ltd.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 748-day FDA review.

K932922 · Cottrell, Ltd. · General Hospital
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Jul 1995
Decision
748d
Days
Class 2
Risk

K932922 is an FDA 510(k) clearance for the PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Cottrell, Ltd. (Englewood, US). The FDA issued a Cleared decision on July 3, 1995 after a review of 748 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cottrell, Ltd. devices

FDA 510(k) Submission Details - K932922

510(k) Number K932922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1993
Decision Date July 03, 1995
Days to Decision 748 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
619d slower than avg
Panel avg: 129d · This submission: 748d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 35
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K932922.
VAPOCIDE
K970726 · Cottrell, Ltd. · May 1998
SPOROX
K970230 · Reckitt Benckiser, Inc. · Oct 1997
PERACT 20 LIQUID STERILANT
K960513 · Minntech Corp. · Oct 1997
WAVICIDE MONITOR STRIPS
K932047 · Serim Research Corp. · Jun 1994
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
K924334 · Johnson & Johnson Medical, Inc. · Mar 1994
PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR
K915170 · Pymah Corp. · Jul 1992