Cleared Traditional

K940147 - AUTO SYRINGE AS40A INFUSION PUMP

K940147 is an FDA 510(k) clearance for AUTO SYRINGE AS40A INFUSION PUMP, manufactured by Baxter Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K940147 · Baxter Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
94d
Days
Class 2
Risk

K940147 is an FDA 510(k) clearance for the AUTO SYRINGE AS40A INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Corp. (Round Lake, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 94 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 Baxter Corp. devices

FDA 510(k) Submission Details - K940147

510(k) Number K940147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1994
Decision Date April 15, 1994
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
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 612
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K940147.
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
CORPAK ENTERAL PUMP
K932847 · Corpak Co. · Jun 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994
RIVER PUMP
K932895 · River Medical, Inc. · Mar 1994
VIVUS 5000 INFUSION SYSTEM
K924527 · I-Flow Corp. · Mar 1994
HI-FLO INFUSION PUMP
K934671 · Abbott Laboratories · Mar 1994