Cleared Traditional

K791894 - 3M BRAND TOTAL LEG COMPRESSION TLC SYS.

K791894 is an FDA 510(k) clearance for 3M BRAND TOTAL LEG COMPRESSION TLC SYS., manufactured by 3M Company. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K791894 · 3M Company · Cardiovascular device
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Nov 1979
Decision
52d
Days
Class 2
Risk

K791894 is an FDA 510(k) clearance for the 3M BRAND TOTAL LEG COMPRESSION TLC SYS.. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 52 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 3M Company devices

FDA 510(k) Submission Details - K791894

510(k) Number K791894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date November 16, 1979
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
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 246
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K791894.
KENDALL SCD THERAPEUTIC SYSTEM
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K881632 · Huntleigh Technology, Inc. · Sep 1988
MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB
K863581 · The Kendal Co. · Oct 1986
SEQUENTIAL CUFF INFLATION DEVICE
K781358 · Medasonics, Inc. · Sep 1978
SEQUENTIAL PRESSURE CUFF
K771083 · Gaymar Industries, Inc. · Jul 1977