510(k) Report

FDA applicant

FUJIFILM Sonosite, Inc.

Bothell, WA25 decisions2013–20261 recall

FDA records 25 decisions for FUJIFILM Sonosite, Inc. (Bothell, WA) from 2013 to 2026: 25 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 27 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 52 predicates, 45 of them its own earlier devices. 1 recall is 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 FUJIFILM Sonosite, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2013: 32014: 12015: 22016: 72017: 12018: 12019: 22020: 22021: 12023: 12025: 32026 (partial year): 1
2013high 7 (2016) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — FUJIFILM Sonosite, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like FUJIFILM 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, Ultrasonic25decisions

How long do its 510(k) reviews take?

Since 2016, its 19 510(k)s took a median of 27 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 79 days; 17 of its 19 were faster than that.

Whose devices does it build on?

Its devices cite 52 predicates; 45 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 52 times; 45 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.

  • K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 201311cite it
  • K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 20167cite it
  • K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 20134cite it
  • K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 20154cite it
  • K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 20163cite it
  • K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 20202cite it

What has FDA decided for it lately?

  • K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc. · 2026
  • K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc. · 2025
  • K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc. · 2025
  • K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2025
  • K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2023
  • K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2021
  • K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite…FUJIFILM Sonosite, Inc. · 2020
  • K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. · 2020

All 25 as FUJIFILM Sonosite, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K113156P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased…Sep 11, 2013Class II

Other applicant names beginning “FUJIFILM”

FDA records each applicant name separately; these may or may not be the same firm.

Fujifilm Medical System U.S.A., Inc. 72Fujifilm Corporation 71Fujifilm Medical Systems U.S.A, Inc. 40FUJIFILM Healthcare Americas Corporation 13Fujifilm Healthcare Corporation 6Fujifilm Corporaton 6Fujifilm Irvine Scientific 5Fujifilm New Development U.S.A., Inc. 3Fujifilm Medwork GmbH 2Fujifilm Meidcal Systems U.S.A.,Inc. 2