Cleared Traditional

K904518 - VOLUMETRIC INFUSION PUMP

K904518 is an FDA 510(k) clearance for VOLUMETRIC INFUSION PUMP, manufactured by Kendall Mcgaw Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K904518 · Kendall Mcgaw Laboratories, Inc. · General Hospital
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Oct 1990
Decision
14d
Days
Class 2
Risk

K904518 is an FDA 510(k) clearance for the VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Kendall Mcgaw Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on October 17, 1990 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 Kendall Mcgaw Laboratories, Inc. devices

FDA 510(k) Submission Details - K904518

510(k) Number K904518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1990
Decision Date October 17, 1990
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 460
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K904518.
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · C.R. Bard, Inc. · Dec 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990
BARD MICROBORE ANTI-SIPHON NITRO SET
K900217 · C.R. Bard, Inc. · Oct 1990
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · Y · Oct 1990
IVAC(R) SYRINGE PUMP - MODEL 740
K903879 · Y · Oct 1990
MULTI DRUG INFUSION SYSTEM
K904048 · I-Flow Corp. · Oct 1990