510(k) Report

FDA applicant

Tayman Medical, Inc.

Chesterfield, MO2 decisions1997–19991 recall

FDA records 2 decisions for Tayman Medical, Inc. (Chesterfield, MO) from 1997 to 1999: 2 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 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 Tayman Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tayman Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tayman Medical, 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?

  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K963302Tayman Medical, Inc. Stepping & Stabilizing SystemTayman Medical, Inc. · 19975cite it

What has FDA decided for it lately?

  • K984382Accu GuideTayman Medical, Inc. · 1999
  • K963302Tayman Medical, Inc. Stepping & Stabilizing SystemTayman Medical, Inc. · 19971 recall

All 2 as Tayman Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K963302AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning…Nov 9, 2006