Cleared Traditional

K852358 - SYRINGE INFUSION PUMP - AS 20 SERIES

K852358 is an FDA 510(k) clearance for SYRINGE INFUSION PUMP - AS 20 SERIES, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K852358 · Baxter Healthcare Corp · General Hospital
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Jul 1985
Decision
32d
Days
Class 2
Risk

K852358 is an FDA 510(k) clearance for the SYRINGE INFUSION PUMP - AS 20 SERIES. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Hooksett, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 32 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.

FDA 510(k) Submission Details - K852358

510(k) Number K852358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1985
Decision Date July 05, 1985
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 848
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K852358.
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985
ENTERAL FEEDING PUMP
K852965 · Empire Industries, Inc. · Aug 1985
VI-FLOW PUMP WITH VI-SET
K851821 · Vital Canada, Inc. · Jul 1985
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · Cardiac Pacemakers, Inc. · Jun 1985
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K852073 · Hospal Medical Corp. · Jun 1985
ENTERAL FEEDING PUMP
K851351 · Empire Industries, Inc. · May 1985
K852358 · SYRINGE INFUSION PUMP - AS 20 SERIES
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