Cleared Traditional

K042217 - FLOWMEDIC, MODEL 220

K042217 is an FDA 510(k) clearance for FLOWMEDIC, manufactured by Flowmedic (Israel), Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K042217 · Flowmedic (Israel), Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
149d
Days
Class 2
Risk

K042217 is an FDA 510(k) clearance for the FLOWMEDIC, MODEL 220. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Flowmedic (Israel), Ltd. (Washington, US). The FDA issued a Cleared decision on January 12, 2005 after a review of 149 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.

FDA 510(k) Submission Details - K042217

510(k) Number K042217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2004
Decision Date January 12, 2005
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 350
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K042217.
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
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GS-128 GRADIENT COMPRESSION SYSTEM
K050584 · Medmark Technologies, LLC · Mar 2005
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · Bio Compression Systems, Inc. · Feb 2005
C-BOOT
K041659 · C-Boot , Ltd. · Oct 2004
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
K040649 · Tyco Healthcare · Jul 2004
SCD EXPRESS PORTABLE COMPRESSION SYSTEM
K040511 · Tyco Healthcare/Kendall · Jun 2004
K042217 · FLOWMEDIC, MODEL 220
Download PDF FDA Summary Flowmedic (Israel), L…