510(k) Report

FDA applicant

Spencer Technologies

Seattle, WA2 decisions2000–20091 recall

FDA records 2 decisions for Spencer Technologies (Seattle, WA) from 2000 to 2009: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 1 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 Spencer Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K002533TCD 100M, PWD13 TransducerSpencer Technologies · 20007cite it

What has FDA decided for it lately?

  • K092204PMD ViewerSpencer Technologies · 2009
  • K002533TCD 100M, PWD13 TransducerSpencer Technologies · 20001 recall

All 2 as Spencer Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K002533Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital…Feb 19, 2004

Other applicant names beginning “Spencer”

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

Spencer Fillmore 3Spencer Products Co. 1