Cleared Traditional

K955107 - SAFESTRIP

K955107 is an FDA 510(k) clearance for SAFESTRIP, manufactured by Firehouse Medical, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K955107 · Firehouse Medical, Inc. · Chemistry device
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Aug 1996
Decision
282d
Days
Class 2
Risk

K955107 is an FDA 510(k) clearance for the SAFESTRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Firehouse Medical, Inc. (Placentia, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 282 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Firehouse Medical, Inc. devices

FDA 510(k) Submission Details - K955107

510(k) Number K955107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1995
Decision Date August 16, 1996
Days to Decision 282 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 88d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K955107.
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ELECT BLOOD GLUCOSE MONITORIG SYSTEM
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K962295 · Medisense, Inc. · Jul 1996
CHEMCARD GLUCOSE TEST
K943503 · Chem-Elec, Inc. · Jul 1996
LXN BLOOD GLUCOSE TEST SYSTEM
K960034 · Lxn Corp. · Jun 1996