Cleared Traditional

K921798 - PROPPER SUPER SERACULT(R) (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921798 · Propper Mfg. Co., Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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.