Cleared Traditional

K151255 - Navigator Aesthetic Delivery System

K151255 is an FDA 510(k) clearance for Navigator Aesthetic Delivery System, 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 232-day FDA review.

K151255 · Carticept Medical, Inc. · General Hospital
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Dec 2015
Decision
232d
Days
Class 2
Risk

K151255 is an FDA 510(k) clearance for the Navigator Aesthetic Delivery System. 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 December 30, 2015 after a review of 232 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Carticept Medical, Inc. devices

FDA 510(k) Submission Details - K151255

510(k) Number K151255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2015
Decision Date December 30, 2015
Days to Decision 232 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
103d slower than avg
Panel avg: 129d · This submission: 232d
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 K151255.
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PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
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HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
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