Cleared Traditional

K142527 - Extension Set with BD Q-Syte Luer Access Split Septum

K142527 is an FDA 510(k) clearance for Extension Set with BD Q-Syte Luer Acces..., manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K142527 · Acacia, Inc. · General Hospital
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Sep 2014
Decision
11d
Days
Class 2
Risk

K142527 is an FDA 510(k) clearance for the Extension Set with BD Q-Syte Luer Access Split Septum. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Acacia, Inc. (Brea, US). The FDA issued a Cleared decision on September 19, 2014 after a review of 11 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 Acacia, Inc. devices

FDA 510(k) Submission Details - K142527

510(k) Number K142527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date September 19, 2014
Days to Decision 11 days
Submission Type Traditional
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
118d faster than avg
Panel avg: 129d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 726
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K142527.
IV ADMINISTRATION SET WITH HAND PUMP
K140838 · B.Braun Medical, Inc. · Dec 2014
Hospira Primary Sets
K142367 · Hospira, Inc. · Nov 2014
MaxZero Administration Sets
K143234 · Care Fusion · Nov 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · B.Braun Medical, Inc. · Aug 2014
SOLUTION SET/EXTENSION SET
K142011 · Baxter Healthcare Corporation · Aug 2014
NEXUS NIS-6P LUER ACTIVATED DEVICE
K133351 · Nexus Medical, LLC · May 2014

FDA 510(k) Resources - General Hospital

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