Cleared Traditional

K964850 - SOLUTION ADMINISTRATION SET WITH 0.22 M...

K964850 is the FDA 510(k) clearance for SOLUTION ADMINISTRATION SET WITH 0.22 M... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K964850 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
84d
Days
Class 2
Risk

K964850 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER. 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 February 25, 1997 after a review of 84 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

Submission Details

510(k) Number K964850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date February 25, 1997
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 467
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964850.
GORE IRRIGATION SET
K964067 · W.L. Gore & Associates, Inc. · Jun 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · Baxter Healthcare Corp · Apr 1997
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
K964844 · Conmedcorp · Mar 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · Vygon Corp. · Feb 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · Medtronic Minimed · Jan 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · Medtronic Minimed · Jan 1997