Cleared Traditional

K901065 - INFUSION PUMP

K901065 is an FDA 510(k) clearance for 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 167-day FDA review.

K901065 · Kendall Mcgaw Laboratories, Inc. · General Hospital
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Aug 1990
Decision
167d
Days
Class 2
Risk

K901065 is an FDA 510(k) clearance for the INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Kendall Mcgaw Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 21, 1990 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kendall Mcgaw Laboratories, Inc. devices

FDA 510(k) Submission Details - K901065

510(k) Number K901065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date August 21, 1990
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 K901065.
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K896075 · Pharmacia Deltec, Inc. · Aug 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K895644 · Pharmacia Deltec, Inc. · Aug 1990
ENTERA-FLO ENTERAL FEEDING PUMP
K894506 · Delmed, Inc. · Aug 1990
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990