Cleared Traditional

K812020 - EGNELL COMPACT, TYPE EHV

K812020 is an FDA 510(k) clearance for EGNELL COMPACT, manufactured by Egnell, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K812020 · Egnell, Inc. · General & Plastic Surgery device
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Oct 1981
Decision
92d
Days
Class 2
Risk

K812020 is an FDA 510(k) clearance for the EGNELL COMPACT, TYPE EHV. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Egnell, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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 Egnell, Inc. devices

FDA 510(k) Submission Details - K812020

510(k) Number K812020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1981
Decision Date October 20, 1981
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 104
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K812020.
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K810490 · Allied Healthcare Products, Inc. · Mar 1981
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K791349 · Stryker Corp. · Sep 1979