Cleared Traditional

K873279 - 8810 PUMP-PUMP SINGLE NEEDLE DEVICE

K873279 is the FDA 510(k) clearance for 8810 PUMP-PUMP SINGLE NEEDLE DEVICE by Cd Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIF) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K873279 · Cd Medical, Inc. · Gastroenterology & Urology device
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Oct 1987
Decision
67d
Days
Class 2
Risk

K873279 is an FDA 510(k) clearance for the 8810 PUMP-PUMP SINGLE NEEDLE DEVICE. Classified as Set, Dialysis, Single Needle With Uni-directional Pump (product code FIF), Class II - Special Controls.

Submitted by Cd Medical, Inc. (Portland, US). The FDA issued a Cleared decision on October 23, 1987 after a review of 67 days - a notably fast clearance cycle.

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: 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 Cd Medical, Inc. devices

Submission Details

510(k) Number K873279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date October 23, 1987
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
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 K873279.
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