Cleared Traditional

K921798 - PROPPER SUPER SERACULT

K921798 is an FDA 510(k) clearance for PROPPER SUPER SERACULT, manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K921798 · Propper Mfg. Co., Inc. · Hematology device
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Oct 1992
Decision
174d
Days
Class 2
Risk

K921798 is an FDA 510(k) clearance for the PROPPER SUPER SERACULT(R). Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 174 days - an extended review 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: 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.

View all Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K921798

510(k) Number K921798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date October 05, 1992
Days to Decision 174 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
61d slower than avg
Panel avg: 113d · This submission: 174d
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 36
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K921798.
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · Labeltape Meditect, Inc. · Oct 1991
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991