510(k) Report

FDA applicant

Sonosite,Inc.

Bothell, WA23 decisions1998–201124 recalls

FDA records 23 decisions for Sonosite,Inc. (Bothell, WA) from 1998 to 2011: 23 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 61 predicates, 29 of them its own earlier devices. 24 recalls are linked to its devices.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sonosite,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 12008: 12009: 12010: 32011: 2
2007high 3 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

15in 2018

2007: 32008: 12010: 22011: 12013: 12018: 15
2007high 15 (2018) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Sonosite,Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonosite,Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic16decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions
  • DSBPlethysmograph, Impedance1decision
  • OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position1decision

Whose devices does it build on?

Its devices cite 61 predicates; 29 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 76 times; 29 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 200513cite it
  • K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 20087cite it
  • K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 20116cite it
  • K014116Hand-Carried Ultrasound SystemSonosite,Inc. · 20016cite it
  • K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 20076cite it
  • K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 20055cite it

What has FDA decided for it lately?

  • K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 20111 recall
  • K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011
  • K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
  • K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 20092 recalls
  • K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 20082 recalls
  • K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 20072 recalls

All 23 as Sonosite,Inc. →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K030064SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers…Nov 2, 2018Class II
  • K030064CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with…Nov 2, 2018Class II
  • K030064CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales…Nov 2, 2018Class II
  • K030064SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile…Nov 2, 2018Class II
  • K030064CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable…Nov 2, 2018Class II
  • K030064CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with…Nov 2, 2018Class II