Cleared Traditional

K911853 - PULSATILE ANTI-EMBOLISM SYS.PUMP

K911853 is an FDA 510(k) clearance for PULSATILE ANTI-EMBOLISM SYS.PUMP, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K911853 · Baxter Healthcare Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
87d
Days
Class 2
Risk

K911853 is an FDA 510(k) clearance for the PULSATILE ANTI-EMBOLISM SYS.PUMP. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 87 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 - K911853

510(k) Number K911853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date July 22, 1991
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 353
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K911853.
JOBST EXTREMITY PUMP SYSTEM 7500
K921562 · Jobst Institute, Inc. · Jun 1992
A-V IMPULSE SYSTEM
K914461 · Novamedix , Ltd. · Apr 1992
COWBOY
K913611 · Kinetic Concepts, Inc. · Jan 1992
FLOWPLUS AC330 PUMP GARMENTS
K910188 · Huntleigh Technology, Inc. · May 1991
VENAPULSE MODELS VP-25 AND VP-50
K903894 · Aci Medical, Inc. · Apr 1991
ZOEX ANTISHOCK TROUSERS
K904267 · Zoex Corp. · Mar 1991
K911853 · PULSATILE ANTI-EMBOLISM SYS.PUMP
Download PDF FDA Summary Baxter Healthcare Corp