# K151255: Navigator Aesthetic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Carticept Medical, Inc.
- Decided: Dec 30, 2015 after 232 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K945773 (1995). 40 ancestors in all.
No later device cites it as a predicate yet.
2 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124053: Navigator Delivery System (Navigator DS), Carticept Medical, Inc. (2013) Summary page 4.
- K123822: Klein Touch Pump and Disposable Tubing Set, Hk Surgical, Inc. (2013) Summary page 4.

## Indications for use
The NavigatorTm AE is an infiltration pump used with the Cellfina handpiece to cause a flow of dilute Lidocaine from a bag for subcutaneous delivery of anesthetic into a patient in a manner controlled manually by a healthcare professional. The Navigator is not intended for use as an IV infusion pump.

Source page: https://510kreport.com/device/K151255
Methodology: https://510kreport.com/methodology