Cleared Traditional

K863470 - DALTEX IV INFUSION PUMP

K863470 is an FDA 510(k) clearance for DALTEX IV INFUSION PUMP, manufactured by Daltex Medical Sciences, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K863470 · Daltex Medical Sciences, Inc. · General Hospital
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Jan 1987
Decision
119d
Days
Class 2
Risk

K863470 is an FDA 510(k) clearance for the DALTEX IV INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Daltex Medical Sciences, Inc. (West Orange, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 119 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 Daltex Medical Sciences, Inc. devices

FDA 510(k) Submission Details - K863470

510(k) Number K863470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1986
Decision Date January 05, 1987
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 619
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K863470.
STRATO(R) PCA INFUSER
K864808 · Strato Medical Corp. · Jan 1987
PERCUPUMP (TM)
K864227 · E-Z-Em, Inc. · Jan 1987
BARD HARVARD MINI-INFUSER 950 PUMP
K864233 · C.R. Bard, Inc. · Jan 1987
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
K864138 · Medtronic Minimed · Dec 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · Abbott Laboratories · Dec 1986
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · Medtronic Minimed · Dec 1986