Cleared Traditional

K813562 - SYRINGE DRIVER 209

K813562 is the FDA 510(k) clearance for SYRINGE DRIVER 209 by Medix Medical Electronics (U.S.A.), Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K813562 · Medix Medical Electronics (U.S.A.), Inc. · General Hospital
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Feb 1982
Decision
41d
Days
Class 2
Risk

K813562 is an FDA 510(k) clearance for the SYRINGE DRIVER 209. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medix Medical Electronics (U.S.A.), Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1982 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medix Medical Electronics (U.S.A.), Inc. devices

Submission Details

510(k) Number K813562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date February 01, 1982
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 307
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K813562.
IVAC 630 & VOLUMETRIC INFUSION PUMP
K821047 · Y · May 1982
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K820860 · Travenol Laboratories, S.A. · Apr 1982
IVAC MODEL 160 AIR-IN-LINE SENSOR
K820764 · Y · Apr 1982
MODEL AS6B INFUSION PUMP
K813590 · Baxter Healthcare Corp · Jan 1982
OPEN LOOP AMBULATORY INSULIN INFUSION
K820073 · Cardiac Pacemakers, Inc. · Jan 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · Baxter Healthcare Corp · Jan 1982