Cleared Traditional

K981318 - DUAL LUER LOCK CAP

K981318 is the FDA 510(k) clearance for DUAL LUER LOCK CAP by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K981318 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
12d
Days
Class 2
Risk

K981318 is an FDA 510(k) clearance for the DUAL LUER LOCK CAP. 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 April 22, 1998 after a review of 12 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 K981318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date April 22, 1998
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
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 465
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K981318.
MANAN BLUNT NEEDLE
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K980583 · Sims Deltec, Inc. · Apr 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
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SMARTVALVE
K974589 · Icu Medical, Inc. · Jan 1998
V3 VALVE
K974145 · B.Braun Medical, Inc. · Jan 1998