Cleared Traditional

K871271 - HUNTLEIGH FLOWPRESS AC300 PUMP

K871271 is an FDA 510(k) clearance for HUNTLEIGH FLOWPRESS AC300 PUMP, manufactured by Huntleigh Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K871271 · Huntleigh Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
168d
Days
Class 2
Risk

K871271 is an FDA 510(k) clearance for the HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Huntleigh Technology, Inc. (Manalapan, US). The FDA issued a Cleared decision on September 15, 1987 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - 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 Huntleigh Technology, Inc. devices

FDA 510(k) Submission Details - K871271

510(k) Number K871271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date September 15, 1987
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRM Device Classification - Class 2, Special Controls

Product Code DRM Compressor, Cardiac, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5200
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 - DRM Compressor, Cardiac, External

Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K871271.
AutoPulse NXT Resuscitation System
K221700 · Zoll Circulation, Inc. · Mar 2023
RMU-2000 Automated Chest Compression System
K211289 · Defibtech, LLC · Nov 2021
LUCAS 3 Chest Compression System
K173553 · Jolife AB · Feb 2018
HUNTLEIGH FLOWPAC FP2000
K871272 · Huntleigh Technology, Inc. · Jun 1987
KEYMED SIGMOIDOSCOPE SUCTION UNIT
K841822 · Keymed, Inc. · Jul 1984