Cleared Traditional

K963049 - STERI-AID KIT

K963049 is an FDA 510(k) clearance for STERI-AID KIT, manufactured by Steri-Aid, Inc.. The device is a Class 1 General Hospital device with product code FQZ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K963049 · Steri-Aid, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
110d
Days
Class 1
Risk

K963049 is an FDA 510(k) clearance for the STERI-AID KIT. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Steri-Aid, Inc. (North York,Ontario, CA). The FDA issued a Cleared decision on November 12, 1996 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2900 - 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.

FDA 510(k) Submission Details - K963049

510(k) Number K963049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1996
Decision Date November 12, 1996
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

FQZ Device Classification - Class 1, General Controls

Product Code FQZ Thermometer, Clinical Color Change
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQZ Thermometer, Clinical Color Change

All 9
Devices cleared under the same product code (FQZ) and FDA review panel - the closest regulatory comparables to K963049.
CRY-ACTRACKERCAM
K110305 · Brymill Cryogenic Cystems · Jan 2012
DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP
K946046 · Deroyal Critical Care, Div. Deroyal Technologies · Jul 1995
POINT CHECKER COLOR STRIP THERMOMETER
K894893 · Kyowa Medex Co., Ltd. · Apr 1990
FRANKLIN COLLECTOR(R)
K884612 · Franklin Diagnostics, Inc. · Mar 1989
TEMPA-DOT CLINICAL THERMOMETER SHEATH
K881286 · Pymah Corp. · Jun 1988
HEALTHCHECK THERM-STRIP
K863181 · Healthcheck Corp. · Sep 1986
K963049 · STERI-AID KIT
Download PDF Steri-Aid, Inc.