Cleared Traditional

K911853 - PULSATILE ANTI-EMBOLISM SYS.PUMP

K911853 is the FDA 510(k) clearance for PULSATILE ANTI-EMBOLISM SYS.PUMP by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (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)
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.

View all Baxter Healthcare Corp devices

Submission Details

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.

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 114
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K911853.
PRESSSION, SEQUENTIAL
K921608 · Chattanooga Group, Inc. · Dec 1992
COWBOY II
K920308 · Kinetic Concepts, Inc. · Aug 1992
COWBOY
K913611 · Kinetic Concepts, Inc. · Jan 1992
SCD KNEE IMMOBILIZER
K895278 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1989
KENDALL SCD THERAPEUTIC SYSTEM
K890938 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1989
MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB
K863581 · The Kendal Co. · Oct 1986