Cleared Special

K041291 - RINSPIRATION SYSTEM

K041291 is an FDA 510(k) clearance for RINSPIRATION SYSTEM, manufactured by Kerberos Proximal Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 7-day FDA review.

K041291 · Kerberos Proximal Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
7d
Days
Class 2
Risk

K041291 is an FDA 510(k) clearance for the RINSPIRATION SYSTEM. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Kerberos Proximal Solutions, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 21, 2004 after a review of 7 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041291

510(k) Number K041291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2004
Decision Date May 21, 2004
Days to Decision 7 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DQO Catheter, Intravascular, Diagnostic

All 489
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K041291.
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
K041123 · Kerberos Proximal Solutions, Inc. · Aug 2004
H-FLOW VALVE
K034043 · Elcam Medical Acal · Jun 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · NuMED, Inc. · Jun 2004
ATLANTIS SR, MODEL C4020
K040776 · Boston Scientific Corp · Apr 2004
CREATION NM DIAGNOSTIC CATHETERS
K032888 · Neich Medical (Shenzhen) Company Limited · Feb 2004
PROGREAT
K033583 · Terumo Medical Corp. · Dec 2003
K041291 · RINSPIRATION SYSTEM
Download PDF FDA Summary Kerberos Proximal Sol…