510(k) · Cleared
ClearedNavigator Aesthetic Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carticept Medical, Inc. · FRN Pump, Infusion
Cleared on Dec 30, 2015 as substantially equivalent to K124053 (Carticept Medical, Inc., 2013) and 1 other predicate after a 232-day review. Its family tree reaches back 11 generations to 1995. 2 of the 41 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 30, 2015
- Review
- 232 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K945773 (1995). 40 ancestors in all, the oldest K890120 (1989). No later device cites it as a predicate yet. 2 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 7 generations between
- 3 generations backK120830 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
- 2 generations backK122215 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
- 1 generation backK124053 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2013
- This deviceK151255 Navigator Aesthetic Delivery SystemCarticept Medical, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 10 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 9 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 8 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 7 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 6 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 5 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 4 generations backK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
- 3 generations backK120830 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
- 2 generations backK122215 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
- 1 generation backK124053 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2013
- This deviceK151255 Navigator Aesthetic Delivery SystemCarticept Medical, Inc. · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −10 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −9 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −8 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −7 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −6 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −5 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −4 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
| −3 | K120830 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2012 | — |
| −2 | K122215 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2012 | — |
| −1 | K124053 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2013 | — |
| 0 (this device) | K151255 | Navigator Aesthetic Delivery System | Carticept Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 1 |
| 2003 | 3 | 0 |
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K124053 | Navigator Delivery System (Navigator DS)Summary page 4…FRN Common or Usual Name: Infusion Pump, External Classification Name: Infusion pump (21 CFR 880.5725) Predicate Device(s): Carticept’s Navigator DS (K124053) HK Surgical’s KleinTouch Pump (K123822) Reference Predicate: The Cellfinal Aesthetic handpiece w… | 2013 |
| * | K123822 | Klein Touch Pump and Disposable Tubing SetSummary page 4…ication Name: Infusion pump (21 CFR 880.5725) Predicate Device(s): Carticept’s Navigator DS (K124053) HK Surgical’s KleinTouch Pump (K123822) Reference Predicate: The Cellfinal Aesthetic handpiece was cleared by FDA on April 14, 2014 as p… | 2013 |
| † | K134010 | Cabochon System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 7 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 40 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151255: Navigator Aesthetic Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151255
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026