Cleared Traditional

K120944 - KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

K120944 is an FDA 510(k) clearance for KENDALL SCD 700 SEQUENTIAL COMPRESSION ..., manufactured by Covidien. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K120944 · Covidien · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
63d
Days
Class 2
Risk

K120944 is an FDA 510(k) clearance for the KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on May 31, 2012 after a review of 63 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.

FDA 510(k) Submission Details - K120944

510(k) Number K120944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2012
Decision Date May 31, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
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 344
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K120944.
A-V FOOT PUMP
K121718 · Dalian Labtek Science & Development Co., Ltd. · Aug 2012
COMPRESSION CARE FLIGHT
K121376 · Medical Minds, LLC · Jul 2012
RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
K121145 · Renu Medical, Inc. · Jun 2012
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
K121001 · Novitas Medical, LLC · Apr 2012
FLEXITOUCH SYSTEM
K120972 · Tactile Systems Technology, Inc. · Apr 2012
ACTIVECARE DVT ACTIVECARE+SFT
K113525 · Medical Compression Systems (Dbn) , Ltd. · Jan 2012
K120944 · KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Download PDF FDA Summary Covidien