Cleared Traditional

K792655 - HELENA COLOSCREEN

K792655 is an FDA 510(k) clearance for HELENA COLOSCREEN, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K792655 · Helena Laboratories · Hematology device
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Jan 1980
Decision
29d
Days
Class 2
Risk

K792655 is an FDA 510(k) clearance for the HELENA COLOSCREEN. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 24, 1980 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K792655

510(k) Number K792655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1979
Decision Date January 24, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
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 K792655.
HELENA COLOSCREEN METHOD
K812428 · Helena Laboratories · Oct 1981
HOME HEALTH CHEKUP KIT
K810488 · Healthkit · May 1981
HELENA COLOCHECK
K800433 · Helena Laboratories · May 1980
FECATEST
K780564 · Otto C. Watzka · Jun 1978
HEMO FEC
K780214 · Boehringer Mannheim Corp. · May 1978
CAMCO R PAK-GUAIAC
K770153 · Cambridge Chemical Products, Inc. · Feb 1977
K792655 · HELENA COLOSCREEN
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