Cleared Traditional

K800337 - DVT PREVENTION SYS. MBE 22 PRESSURE U.

K800337 is an FDA 510(k) clearance for DVT PREVENTION SYS. MBE 22 PRESSURE U., manufactured by Med-Bio Engineering, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K800337 · Med-Bio Engineering, Inc. · Cardiovascular device
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Mar 1980
Decision
39d
Days
Class 2
Risk

K800337 is an FDA 510(k) clearance for the DVT PREVENTION SYS. MBE 22 PRESSURE U.. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Med-Bio Engineering, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 39 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 Med-Bio Engineering, Inc. devices

FDA 510(k) Submission Details - K800337

510(k) Number K800337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1980
Decision Date March 25, 1980
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
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 314
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K800337.
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 CUFF INFLATION DEVICE
K781358 · Medasonics, Inc. · Sep 1978
SEQUENTIAL PRESSURE CUFF
K771083 · Gaymar Industries, Inc. · Jul 1977