Cleared Traditional

K853393 - INSULIN PUMP INSUMAT 229

K853393 is an FDA 510(k) clearance for INSULIN PUMP INSUMAT 229, manufactured by Medix Medical Electronics (U.S.A.), Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K853393 · Medix Medical Electronics (U.S.A.), Inc. · General Hospital
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Nov 1985
Decision
98d
Days
Class 2
Risk

K853393 is an FDA 510(k) clearance for the INSULIN PUMP INSUMAT 229. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medix Medical Electronics (U.S.A.), Inc. (New York, US). The FDA issued a Cleared decision on November 18, 1985 after a review of 98 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 Medix Medical Electronics (U.S.A.), Inc. devices

FDA 510(k) Submission Details - K853393

510(k) Number K853393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date November 18, 1985
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 K853393.
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · Medex, Inc. · Jan 1986
FLUID MANAGEMENT SYSTEM
K852645 · Haemonetics Corp. · Dec 1985
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K853134 · Erika, Inc. · Nov 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985
SYRINGE INFUSION PUMP - AS 20 SERIES
K852358 · Baxter Healthcare Corp · Jul 1985