Cleared Traditional

K821696 - THE SOFT PEDAL

K821696 is an FDA 510(k) clearance for THE SOFT PEDAL, manufactured by Habco Products, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K821696 · Habco Products, Inc. · Cardiovascular device
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Jul 1982
Decision
36d
Days
Class 2
Risk

K821696 is an FDA 510(k) clearance for the THE SOFT PEDAL. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Habco Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 36 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 Habco Products, Inc. devices

FDA 510(k) Submission Details - K821696

510(k) Number K821696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date July 14, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 313
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K821696.
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