Cleared Traditional

K912979 - HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION

K912979 is an FDA 510(k) clearance for HEMAWIPE SYSTEM, manufactured by Labeltape Meditect, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K912979 · Labeltape Meditect, Inc. · Hematology device
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Oct 1991
Decision
123d
Days
Class 2
Risk

K912979 is an FDA 510(k) clearance for the HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K912979

510(k) Number K912979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date October 04, 1991
Days to Decision 123 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 113d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHE Device Classification - Class 2, Special Controls

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K912979.
HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES
K936056 · Dipro Diagnostic Products GmbH · Apr 1995
PROPPER SUPER SERACULT(R)
K921798 · Propper Mfg. Co., Inc. · Oct 1992
HEMOPLUS
K913622 · Sarstedt, Inc. · Jan 1992
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
FHT (FECAL HEME TEST)
K905782 · Aerscher, Inc. · May 1991
K912979 · HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
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