Cleared Traditional

K802230 - BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP

K802230 is the FDA 510(k) clearance for BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP by Cardio Med Supplies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIF) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K802230 · Cardio Med Supplies, Inc. · Gastroenterology & Urology device
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Dec 1980
Decision
97d
Days
Class 2
Risk

K802230 is an FDA 510(k) clearance for the BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP. Classified as Set, Dialysis, Single Needle With Uni-directional Pump (product code FIF), Class II - Special Controls.

Submitted by Cardio Med Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Med Supplies, Inc. devices

Submission Details

510(k) Number K802230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date December 22, 1980
Days to Decision 97 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 130d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIF Set, Dialysis, Single Needle With Uni-directional Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIF Set, Dialysis, Single Needle With Uni-directional Pump

Devices cleared under the same product code (FIF) and FDA review panel - the closest regulatory comparables to K802230.
COBE SINGLE-NEEDLE CONTROLLER #18-756
K820173 · Cobe Laboratories, Inc. · Mar 1982
MEDCOMP FEMORAL VEIN CATHETER
K801967 · Medical Components, Inc. · Sep 1980
MODEL DM 353 & DM-353-L SINGLE NEEDLE
K792174 · Extracorporeal Medical Specialities, Inc. · Nov 1979
GW 35 GUIDE WIRE
K772147 · Sorensen Research · Nov 1977