Cleared Traditional

K082149 - LYMPHA PRESS OPTIMAL, MODEL# 1201AP

K082149 is an FDA 510(k) clearance for LYMPHA PRESS OPTIMAL, manufactured by Mego Afek AC , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K082149 · Mego Afek AC , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
68d
Days
Class 2
Risk

K082149 is an FDA 510(k) clearance for the LYMPHA PRESS OPTIMAL, MODEL# 1201AP. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Mego Afek AC , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on October 6, 2008 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mego Afek AC , Ltd. devices

FDA 510(k) Submission Details - K082149

510(k) Number K082149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date October 06, 2008
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
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 323
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