Cleared Traditional

K810803 - FREEZE DRIED PAPAIN

K810803 is an FDA 510(k) clearance for FREEZE DRIED PAPAIN, manufactured by Biological Corp. of America. The device is a Class 2 Immunology device with product code KSK cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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.

FDA 510(k) Submission Details - K810803

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 105d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSK Device Classification - Class 2, Special Controls

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.

K810803 · FREEZE DRIED PAPAIN
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