Cleared Traditional

SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR (K861456) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K861456 · Pantheon Products, Inc. · General & Plastic Surgery device
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Jul 1986
Decision
98d
Days
Class 1
Risk

K861456 is an FDA 510(k) clearance for the SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR. Classified as Pad, Eye (product code HMP), Class I - General Controls.

Submitted by Pantheon Products, Inc. (Odessa, US). The FDA issued a Cleared decision on July 25, 1986 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4440 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pantheon Products, Inc. devices

Submission Details

510(k) Number K861456 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 18, 1986
Decision Date July 25, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMP Pad, Eye
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4440
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.