Cleared Traditional

K143588 - Surefire Infusion System 021

K143588 is an FDA 510(k) clearance for Surefire Infusion System 021, manufactured by Surefire Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K143588 · Surefire Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
25d
Days
Class 2
Risk

K143588 is an FDA 510(k) clearance for the Surefire Infusion System 021. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Surefire Medical, Inc. (Westminster, US). The FDA issued a Cleared decision on January 12, 2015 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Surefire Medical, Inc. devices

FDA 510(k) Submission Details - K143588

510(k) Number K143588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date January 12, 2015
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular 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 - DQO Catheter, Intravascular, Diagnostic

All 435
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K143588.
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
K143604 · Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · Jun 2015
IntraNovo 25 Microcatheter
K142817 · Texasmedical Technologies, Inc. · Apr 2015
SUMMED HIGH PRESSURE LINE
K140356 · Sunny Medical Device (Shenzhen) Co., Ltd. · Mar 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · Cook, Inc. · Jan 2015
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
K141453 · Lightlab Imaging, Inc. · Sep 2014
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
K141769 · Lightlab Imaging, Inc. · Aug 2014