Cleared Traditional

AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM) (K951684) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951684 · Digital Air Corp. · Cardiovascular device
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Oct 1995
Decision
178d
Days
Class 2
Risk

K951684 is an FDA 510(k) clearance for the AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Digital Air Corp. (Dallas, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 178 days - an extended review 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: 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 Digital Air Corp. devices

Submission Details

510(k) Number K951684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1995
Decision Date October 06, 1995
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K951684.
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · Devon Medical Products (Jiangsu), Ltd. · Feb 2018
Medline Hemo-Force DVT Compression Sleeve
K170415 · Medline Industries, Inc. · Sep 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · Baxter Healthcare Corp · Jul 1991
3M BRAND TOTAL LEG COMPRESSION TLC SYS.
K791894 · 3M Company · Nov 1979