Cleared Traditional

K781358 - SEQUENTIAL CUFF INFLATION DEVICE

K781358 is an FDA 510(k) clearance for SEQUENTIAL CUFF INFLATION DEVICE, manufactured by Medasonics, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K781358 · Medasonics, Inc. · Cardiovascular device
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Sep 1978
Decision
43d
Days
Class 2
Risk

K781358 is an FDA 510(k) clearance for the SEQUENTIAL CUFF INFLATION DEVICE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 43 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 Medasonics, Inc. devices

FDA 510(k) Submission Details - K781358

510(k) Number K781358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1978
Decision Date September 20, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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 125
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K781358.
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