Cleared Traditional

K961495 - HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE

K961495 is an FDA 510(k) clearance for HUBER NEEDLE EXTENSION SET WITH STANDAR..., 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 69-day FDA review.

K961495 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
69d
Days
Class 2
Risk

K961495 is an FDA 510(k) clearance for the HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECT.... 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 26, 1996 after a review of 69 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 - K961495

510(k) Number K961495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date June 26, 1996
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 812
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K961495.
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · Merit Medical Systems, Inc. · Aug 1996
I.V. ADMINISTRATION SETS
K955821 · Medical Associates Network, Inc. · Jul 1996
STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
K960391 · Strato/Infusaid, Inc. · Jul 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · Baxter Healthcare Corp · Jun 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · Abbott Laboratories · May 1996
V2 INJECTION SITE
K955585 · B.Braun Medical, Inc. · May 1996