Cleared Traditional

K090134 - INTRAVENOUS POWER INJECTOR EXTENSION SET

K090134 is an FDA 510(k) clearance for INTRAVENOUS POWER INJECTOR EXTENSION SET, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K090134 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
90d
Days
Class 2
Risk

K090134 is an FDA 510(k) clearance for the INTRAVENOUS POWER INJECTOR EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 21, 2009 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K090134

510(k) Number K090134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date April 21, 2009
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 749
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K090134.
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
K093773 · Amsino International, Inc. · Mar 2010
NEXUS INJECTION SITE, MODEL NIS-8
K092527 · Nexus Medical, LLC · Feb 2010
A6 LUER ACCESS DEVICE
K083723 · B.Braun Medical, Inc. · Jun 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · Icu Medical, Inc. · Apr 2009
SPINNING SPIROS, MODEL CH-2000
K082806 · Icu Medical, Inc. · Apr 2009
MISER CONTRAST MANAGEMENT SYSTEM
K083576 · Merit Medical Systems, Inc. · Dec 2008