Cleared Traditional

AMBULATORY INFUSION SYSTEM AND ACCESSORIES (K894028) - FDA 510(k) Clearance

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

K894028 · Patient Solutions, Inc. · General Hospital
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Dec 1989
Decision
199d
Days
Class 2
Risk

K894028 is an FDA 510(k) clearance for the AMBULATORY INFUSION SYSTEM AND ACCESSORIES. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Patient Solutions, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 199 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 Patient Solutions, Inc. devices

Submission Details

510(k) Number K894028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1989
Decision Date December 22, 1989
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K894028.
AVI MICRO 210CM INFUSION PUMP
K897013 · 3M Company · Mar 1990
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · Baxter Healthcare Corp · Feb 1990
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
MODEL 600 SYRINGE PUMP
K891237 · 3M Company · Dec 1989
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K894292 · C.R. Bard, Inc. · Nov 1989
MODEL 285 INFUSION PUMP
K894321 · 3M Company · Oct 1989