Cleared Traditional

K961225 - CONTINUFLO SOLUTION SET/SECONDARY MEDIC...

K961225 is the FDA 510(k) clearance for CONTINUFLO SOLUTION SET/SECONDARY MEDIC... 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.

K961225 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
84d
Days
Class 2
Risk

K961225 is an FDA 510(k) clearance for the CONTINUFLO SOLUTION SET/SECONDARY MEDICATION 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 June 21, 1996 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 K961225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1996
Decision Date June 21, 1996
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 473
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K961225.
DELTEC SUBCUTANEOUS INFUSION SET
K963009 · Sims Deltec, Inc. · Oct 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · Merit Medical Systems, Inc. · Aug 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
K961495 · Baxter Healthcare Corp · Jun 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · Abbott Laboratories · May 1996
V2 INJECTION SITE
K955585 · B.Braun Medical, Inc. · May 1996
SNAPDOSE DEVICE
K955410 · Abbott Laboratories · May 1996