Cleared Traditional

I.V. TEAMATE (K842479) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842479 · Medical Delivery Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
130d
Days
Class 2
Risk

K842479 is an FDA 510(k) clearance for the I.V. TEAMATE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medical Delivery Systems (Irvine, US). The FDA issued a Cleared decision on November 2, 1984 after a review of 130 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 Medical Delivery Systems devices

Submission Details

510(k) Number K842479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1984
Decision Date November 02, 1984
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K842479.
ABBOTT LIFECARE 500 INFUSER
K844768 · Abbott Laboratories · Jan 1985
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · Intermedics, Inc. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · Abbott Laboratories · Jun 1984