Cleared Traditional

K950303 - DESERET I.V. LOOP AND DESERET J LOOP

K950303 is an FDA 510(k) clearance for DESERET I.V. LOOP AND DESERET J LOOP, manufactured by Becton Dickinson Vascular Access, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K950303 · Becton Dickinson Vascular Access, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
48d
Days
Class 2
Risk

K950303 is an FDA 510(k) clearance for the DESERET(R) I.V. LOOP AND DESERET (R) J LOOP. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 48 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 Becton Dickinson Vascular Access, Inc. devices

FDA 510(k) Submission Details - K950303

510(k) Number K950303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1995
Decision Date March 14, 1995
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K950303.
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · Baxter Healthcare Corp · Jul 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922 · Imed Corp. · Jul 1995
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
K952053 · Becton Dickinson Vascular Access, Inc. · May 1995
DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
K950304 · Becton Dickinson Vascular Access, Inc. · Mar 1995
E-Z SET(R) AND MINICATH(R) INFUSION SETS
K950302 · Becton Dickinson Vascular Access, Inc. · Mar 1995
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
K944320 · Imed Corp. · Feb 1995