Cleared Traditional

FREEZE DRIED PAPAIN (K810803) - FDA 510(k) Clearance

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

K810803 · Biological Corp. of America · Immunology device
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Jul 1981
Decision
119d
Days
Class 2
Risk

K810803 is an FDA 510(k) clearance for the FREEZE DRIED PAPAIN. Classified as Solution, Stabilized Enzyme (product code KSK), Class II - Special Controls.

Submitted by Biological Corp. of America (Mchenry, US). The FDA issued a Cleared decision on July 21, 1981 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.9400 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biological Corp. of America devices

Submission Details

510(k) Number K810803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date July 21, 1981
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 104d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSK Solution, Stabilized Enzyme
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9400
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 Immunology devices follow this clearance model.