Cleared Traditional

K961166 - FLOWTRON EXCEL PUMP (FDA 510(k) Clearance)

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

K961166 · Hne Healthcare, Inc. · Cardiovascular device
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Oct 1996
Decision
200d
Days
Class 2
Risk

K961166 is an FDA 510(k) clearance for the FLOWTRON EXCEL PUMP. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Hne Healthcare, Inc. (Manalapan, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 200 days - an extended review 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: 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 Hne Healthcare, Inc. devices

Submission Details

510(k) Number K961166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1996
Decision Date October 11, 1996
Days to Decision 200 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 125d · This submission: 200d
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 349
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