Cleared Abbreviated

K103562 - CENTURION PRESSURE INJECTABLE EXTENSION SET

K103562 is an FDA 510(k) clearance for CENTURION PRESSURE INJECTABLE EXTENSION SET, manufactured by Centurion Medical Products Corporation. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 199-day FDA review.

K103562 · Centurion Medical Products Corporation · General Hospital
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Jun 2011
Decision
199d
Days
Class 2
Risk

K103562 is an FDA 510(k) clearance for the CENTURION PRESSURE INJECTABLE EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Centurion Medical Products Corporation (Williamston, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 199 days - an extended review 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 Centurion Medical Products Corporation devices

FDA 510(k) Submission Details - K103562

510(k) Number K103562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date June 23, 2011
Days to Decision 199 days
Submission Type Abbreviated
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
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Standards-based clearance path.

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 770
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