Cleared Traditional

K981792 - SOLUTION ADMINISTRATION SET

K981792 is an FDA 510(k) clearance for SOLUTION ADMINISTRATION SET, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K981792 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
88d
Days
Class 2
Risk

K981792 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on August 17, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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

FDA 510(k) Submission Details - K981792

510(k) Number K981792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date August 17, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 791
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K981792.
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
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COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · Baxter Healthcare Corp · Sep 1998
MPS FIXED FLOW RATE SET
K982587 · Medical Product Specialists · Aug 1998
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y
K981683 · Venusa , Ltd. · Jul 1998
MPS HUBER NEEDLE EXTENSION SET
K982047 · Medical Product Specialists · Jul 1998
CONTRAST CONTROL DEVICE
K982123 · Medex, Inc. · Jul 1998