Cleared Traditional

K813473 - 5B SLAVE MODULE SYRINGE PUMP

K813473 is the FDA 510(k) clearance for 5B SLAVE MODULE SYRINGE PUMP by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K813473 · Baxter Healthcare Corp · General Hospital
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Jan 1982
Decision
39d
Days
Class 2
Risk

K813473 is an FDA 510(k) clearance for the 5B SLAVE MODULE SYRINGE PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 39 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K813473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1981
Decision Date January 22, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 129d · This submission: 39d
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 443
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K813473.
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
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · Travenol Laboratories, S.A. · Dec 1981
PERSONAL MEDICATION INFUSER
K810850 · Pacesetter Systems · Nov 1981
PORTABLE LIDOCAINE INFUSION PUMP
K812917 · Cardiac Pacemakers, Inc. · Nov 1981