Cleared Special

K122215 - NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

K122215 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 Special 510(k) pathway after a 93-day FDA review.

K122215 · Carticept Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
93d
Days
Class 2
Risk

K122215 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 October 26, 2012 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device 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. Standard predicate reliance. 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 - K122215

510(k) Number K122215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date October 26, 2012
Days to Decision 93 days
Submission Type Special
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
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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 657
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K122215.
AGILIA INFUSION SYSTEM
K121613 · Fresenius Kabi AG · May 2013
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K124053 · Carticept Medical, Inc. · Mar 2013
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K111275 · Smiths Medical Asd, Inc. · Feb 2013
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K120830 · Carticept Medical, Inc. · Apr 2012
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
K110535 · Carefusion 303, Inc. · Mar 2012
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · Hospira, Inc. · Mar 2012