Cleared Traditional

K871272 - HUNTLEIGH FLOWPAC FP2000 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871272 · Huntleigh Technology, Inc. · Cardiovascular device
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Jun 1987
Decision
86d
Days
Class 2
Risk

K871272 is an FDA 510(k) clearance for the HUNTLEIGH FLOWPAC FP2000. 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 June 25, 1987 after a review of 86 days - a notably fast clearance 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: 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 Huntleigh Technology, Inc. devices

Submission Details

510(k) Number K871272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date June 25, 1987
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.