Cleared Traditional

K953584 - LIFESHIELD LUER ACTIVATED VALVE MALE AD...

K953584 is an FDA 510(k) clearance for LIFESHIELD LUER ACTIVATED VALVE MALE AD..., manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K953584 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
84d
Days
Class 2
Risk

K953584 is an FDA 510(k) clearance for the LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 24, 1995 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K953584

510(k) Number K953584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date October 24, 1995
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
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.

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 K953584.
SIMS DELTEC ANTI-SIPHON VALVE
K954870 · Sims Deltec, Inc. · Dec 1995
ICU EXTENSION KIT
K954813 · Icu Medical, Inc. · Nov 1995
LOW PROFILE SAFSITE Y-SITE
K954123 · B.Braun Medical, Inc. · Nov 1995
IVAC BALL VALCE ADMIN. SETS
K953225 · Y · Sep 1995
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
K952160 · Medex, Inc. · Sep 1995
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
K950153 · Imed Corp. · Aug 1995