Cleared Traditional

K771300 - INTRAVENOUS INFUSION PUMP

K771300 is an FDA 510(k) clearance for INTRAVENOUS INFUSION PUMP, manufactured by Stewart-Naumann Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K771300 · Stewart-Naumann Laboratories · General Hospital
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Dec 1977
Decision
148d
Days
Class 2
Risk

K771300 is an FDA 510(k) clearance for the INTRAVENOUS INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Stewart-Naumann Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 8, 1977 after a review of 148 days - within the typical 510(k) review window.

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 Stewart-Naumann Laboratories devices

FDA 510(k) Submission Details - K771300

510(k) Number K771300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1977
Decision Date December 08, 1977
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 624
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K771300.
INFUSION PUMP, PEDIATRIC MODEL 301
K781171 · Imed Corp. · Aug 1978
INFUSION PUMP
K780503 · Air-Shields, Inc. · Apr 1978
INFUSION APPARATUS, POWERED
K780086 · Ohio Medical Products · Jan 1978
LIFECARE I.V. PUMP - MODEL III
K772094 · Abbott Laboratories · Dec 1977
VOLUMETRIC INFUSION PUMP MODEL 960
K771664 · Imed Corp. · Sep 1977
I.V. PUMP, ABBOTT/SHAW LIFECARE
K770087 · Abbott Laboratories · Feb 1977