Cleared Traditional

K112067 - NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

K112067 is an FDA 510(k) clearance for NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS), manufactured by Carticept Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K112067 · Carticept Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
59d
Days
Class 2
Risk

K112067 is an FDA 510(k) clearance for the NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Carticept Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 16, 2011 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Carticept Medical, Inc. devices

FDA 510(k) Submission Details - K112067

510(k) Number K112067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2011
Decision Date September 16, 2011
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 481
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K112067.
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · Baxter Healthcare Corporation · May 2014
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K111275 · Smiths Medical Asd, Inc. · Feb 2013
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · Hospira, Inc. · Mar 2012
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
K111386 · Smiths Medical MD, Inc. · Aug 2011
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
K100798 · Medrad, Inc. · Jun 2010
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · B.Braun Medical, Inc. · Jul 2009