Cleared Traditional

K895278 - SCD KNEE IMMOBILIZER

K895278 is an FDA 510(k) clearance for SCD KNEE IMMOBILIZER, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K895278 · Kendall Healthcare Products Co. Div.Of Tyco Health · Cardiovascular device
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Nov 1989
Decision
99d
Days
Class 2
Risk

K895278 is an FDA 510(k) clearance for the SCD KNEE IMMOBILIZER. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 99 days - within the typical 510(k) review window.

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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K895278

510(k) Number K895278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date November 30, 1989
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 K895278.
COWBOY
K913611 · Kinetic Concepts, Inc. · Jan 1992
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · Baxter Healthcare Corp · Jul 1991
FLOWPLUS AC330 PUMP GARMENTS
K910188 · Huntleigh Technology, Inc. · May 1991
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