# K112067: Navigator Delivery System (Navigator DS)

- Pathway: 510(k) (Traditional)
- Applicant: Carticept Medical, Inc.
- Decided: Sep 16, 2011 after 59 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: 7 generations back to K945773 (1995). 34 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101194: Navigator Delivery System (or Navigator DS) Model: Nav-010, Carticept Medical, Inc. (2011) Summary page 2.
- K082098: Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K100994: Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120830: Navigator Delivery System (Navigator DS) (2012), 3 descendants of its own
- K122215: Navigator Delivery System (Navigator DS) (2012), 2 descendants of its own
- K124053: Navigator Delivery System (Navigator DS) (2013), 1 descendant of its own
- K151255: Navigator Aesthetic Delivery System (2015), 0 descendants of its own

## Indications for use
The Navigator DS Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.

Source page: https://510kreport.com/device/K112067
Methodology: https://510kreport.com/methodology