510(k) Report

510(k) · Cleared

Cleared

Lumenvu Catheter Guidance System

K093510510(k) TraditionalCleared Aug 23, 2010284-day reviewClass II21 CFR 880.5970

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sonosite,Inc. · OMF Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

Cleared on Aug 23, 2010 as substantially equivalent to K083121 (Corpak Medsystems, 2009) and 2 other predicates after a 284-day review. Its family tree reaches back 7 generations to 2000.

Decided
Aug 23, 2010
Review
284 days
Class
Class II
Product code
OMF
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K001901 (2000). 29 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2006: 2 other ancestors2004: 1 other ancestor2002: 2 other ancestors1997: 1 other ancestor1992: 2 other ancestors2000: 1 other ancestor1996: 2 other ancestors1995: 2 other ancestors1994: 3 other ancestors1993: 1 other ancestor1991: 2 other ancestors1986: 1 other ancestor1982: 1 other ancestorK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK060341 · Sherlock Tip Location System (TLS) · C.R. Bard, Inc. · 2006K063240 · Sherlock TLS Stylet, Sherlock TLS Detector · C.R. Bard, Inc. · 2006 · recalledK081625 · Flowpicc Stylet · Vasonova, Inc. · 20081980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 4 other ancestors4 generations back: 13 other ancestors5 generations back: 2 other ancestors K081625 · Flowpicc Stylet · Vasonova, Inc. · 2008K063240 · Sherlock TLS Stylet, Sherlock TLS Detector · C.R. Bard, Inc. · 2006 · recalledK060341 · Sherlock Tip Location System (TLS) · C.R. Bard, Inc. · 2006K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
  6. 2 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
  7. 1 generation backK081625 Flowpicc StyletVasonova, Inc. · 2008
  8. This deviceK093510 Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.2006—
−2K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc.200618
−1K081625Flowpicc StyletVasonova, Inc.2008—
0 (this device)K093510Lumenvu Catheter Guidance SystemSonosite,Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198610
199120
199220
199310
199430
199520
199620
199710
200010
200220
200410
200620
200910
FIG. 1 — Lineage of K093510, 2000–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K083121Neo Mapcath Sensor Stylet
Summary page 1
…evices 21 CEFR. § 880.5970 Product Codes: OMF Predicate Device Information NEO MAPcath Sensor Stylet (Corpak MedSystem) - K083 121 ElowPICC Stylet (VasoNova, Inc.) - K081625 InfraReDx NIR Imaging System (InfiaReDx, Inc.) - K052908 Intended Use!/ Indication…
Corpak Medsystems2009—
*K081625Flowpicc Stylet
Summary page 1
…§ 880.5970 Product Codes: OMF Predicate Device Information NEO MAPcath Sensor Stylet (Corpak MedSystem) - K083 121 ElowPICC Stylet (VasoNova, Inc.) - K081625 InfraReDx NIR Imaging System (InfiaReDx, Inc.) - K052908 Intended Use!/ Indications for Use The LumenVUTM Catheter Guidance S…
Vasonova, Inc.2008—
*K052908Intraredx Nir Imaging System, Model MC-5
Summary page 1
…Device Information NEO MAPcath Sensor Stylet (Corpak MedSystem) - K083 121 ElowPICC Stylet (VasoNova, Inc.) - K081625 InfraReDx NIR Imaging System (InfiaReDx, Inc.) - K052908 Intended Use!/ Indications for Use The LumenVUTM Catheter Guidance System is intended to aid in the placement of peripherally…
Infraredx, Inc.2006—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 5 of the 29 ancestors have a recall of any class.

How does its category compare?

All OMF devices

OMF Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OMF

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMF

Too few OMF 510(k)s in any year since 2007 to give a median.

Recalls per year · OMF

No recall names OMF since 2007.

Adverse event reports per year · OMF

1in 2017

2010: 12013: 62017: 1
2007high 6 (2013) · low 0 (2007)2025

MAUDE reports naming product code OMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20101—01
20110—00
20120—00
20130—06
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The LumenVUTM Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (P1CC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.

Indications for use as stated in the FDA summary.

More from Sonosite,Inc.

23 FDA decisions under this applicant name. See the company

  • K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 20111 recall
  • K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011
  • K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 20092 recalls

Recent decisions in OMF

The OMF category page

  • K083121Neo Mapcath Sensor StyletCorpak Medsystems · 2009

https://510kreport.com/device/K093510 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093510: Lumenvu Catheter Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093510

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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