Cleared Abbreviated

K040385 - MULTIPORT MANIFOLD SET WITH SWABABLE VA...

K040385 is the FDA 510(k) clearance for MULTIPORT MANIFOLD SET WITH SWABABLE VA... by Quest Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Abbreviated 510(k) pathway after a 50-day FDA review.

K040385 · Quest Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2004
Decision
50d
Days
Class 2
Risk

K040385 is an FDA 510(k) clearance for the MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 50 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Quest Medical, Inc. devices

Submission Details

510(k) Number K040385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date April 07, 2004
Days to Decision 50 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEREMI PECK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPA Set, Administration, Intravascular

All 448
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K040385.
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · Icu Medical, Inc. · Jul 2004
SPLIT SEPTUM INJECTION SITES
K041042 · Fresenius Medical Care North America · Jul 2004
TALON INFUSION SET, MODEL IP XXXX
K033290 · Icu Medical, Inc. · Apr 2004
CLC2000 CATHETER PATENCY DEVICE
K021692 · Icu Medical, Inc. · Dec 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576 · Abbott Laboratories · Dec 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · Becton, Dickinson & CO · Nov 2003

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.