Cleared Traditional

K961166 - FLOWTRON EXCEL PUMP

K961166 is an FDA 510(k) clearance for FLOWTRON EXCEL PUMP, manufactured by Hne Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K961166 · Hne Healthcare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961166

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
Combination Product No
PCCP Authorized No
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.

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 326
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K961166.
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
K961797 · Wright Linear Pump, Inc. · Nov 1996
WLP SINGLE-SEGMENT VERSION WLP SOLO VII
K961891 · Wright Linear Pump, Inc. · Nov 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM
K954788 · Eureduc · Oct 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
K960902 · Eureduc · Sep 1996
HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM
K955853 · Healthcare Service and Supply · Jun 1996
M.I.C.
K950967 · V.V.T. Healthcare Technologies, Inc. · May 1996