Cleared Traditional

K972763 - HEMAPROMPT

K972763 is the FDA 510(k) clearance for HEMAPROMPT by Aerscher Diagnostics. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K972763 · Aerscher Diagnostics · Hematology device
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Oct 1997
Decision
88d
Days
Class 2
Risk

K972763 is an FDA 510(k) clearance for the HEMAPROMPT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Aerscher Diagnostics (Chestertown, US). The FDA issued a Cleared decision on October 20, 1997 after a review of 88 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.

View all Aerscher Diagnostics devices

Submission Details

510(k) Number K972763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date October 20, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K972763.
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
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COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991