Cleared Traditional

K810338 - LYMPHA PRESS

K810338 is an FDA 510(k) clearance for LYMPHA PRESS, manufactured by Mego Afek. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K810338 · Mego Afek · Cardiovascular device
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Oct 1981
Decision
253d
Days
Class 2
Risk

K810338 is an FDA 510(k) clearance for the LYMPHA PRESS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Mego Afek (Walker, US). The FDA issued a Cleared decision on October 20, 1981 after a review of 253 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Mego Afek devices

FDA 510(k) Submission Details - K810338

510(k) Number K810338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1981
Decision Date October 20, 1981
Days to Decision 253 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 125d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K810338.
KENDALL SCD THERAPEUTIC SYSTEM
K890938 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1989
FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
K881632 · Huntleigh Technology, Inc. · Sep 1988
MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB
K863581 · The Kendal Co. · Oct 1986
3M BRAND TOTAL LEG COMPRESSION TLC SYS.
K791894 · 3M Company · Nov 1979
SEQUENTIAL PRESSURE CUFF
K771083 · Gaymar Industries, Inc. · Jul 1977