510(k) Report

FDA applicant

Diagnostic Ultrasound Corp.

Kirkland, WA16 decisions1985–20031 recall

FDA records 16 decisions for Diagnostic Ultrasound Corp. (Kirkland, WA) from 1985 to 2003: 16 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…). Its devices cite 8 predicates, 6 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 Diagnostic Ultrasound Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostic Ultrasound Corp. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Diagnostic Ultrasound Corp.’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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic6decisions
  • FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device3decisions
  • FFXSystem, Gastrointestinal Motility (Electrical)1decision
  • DPWFlowmeter, Blood, Cardiovascular1decision
  • JOPTransducer, Ultrasonic1decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision

Also: LLZ (1), DXT (1), EXY (1).

Whose devices does it build on?

Its devices cite 8 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 6 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.

  • K022153Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 20023cite it
  • K030763Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp. · 20033cite it
  • K915436Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 19923cite it
  • K955840Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 19962cite it

What has FDA decided for it lately?

  • K030763Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp. · 20031 recall
  • K022153Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 20021 recall
  • K982568Bladdermanager Pci 5000 Model 1002Diagnostic Ultrasound Corp. · 1999
  • K963585Bladder Manager Pci 5000, Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
  • K955840Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
  • K955942Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
  • K920664Diagnostic Ultrasound/Uro-Gyn Ups 2020, GI VersionDiagnostic Ultrasound Corp. · 1993
  • K915342UD 2000 Video OptionDiagnostic Ultrasound Corp. · 1992

All 16 as Diagnostic Ultrasound Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K022153The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON…Sep 20, 2010

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Systems Laboratories, Inc. 94Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic Reagents, Inc. 66Diagnostic Chemicals, Ltd. 66Diagnostic Hybrids, Inc. 37Diagnostic Technology, Inc. 28Diagnostic Solutions, Inc. 26Diagnostic Systems 14Diagnostic Reagent Tech. 10Diagnostic Specialties 8Diagnostic Monitoring Software 5