510(k) Report

FDA applicant

Kleinfeld, Kaplan and Becker

Washington, DC2 decisions1995–19960 recalls

FDA records 2 decisions for Kleinfeld, Kaplan and Becker (Washington, DC) from 1995 to 1996: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IOR (Wheelchair, Mechanical). No 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 Kleinfeld, Kaplan and Becker’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kleinfeld, Kaplan and Becker since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • IORWheelchair, Mechanical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K945957Ausonics Opus 2 Realtime Ultrasound ScannerKleinfeld, Kaplan and Becker · 19961cites it

What has FDA decided for it lately?

  • K945957Ausonics Opus 2 Realtime Ultrasound ScannerKleinfeld, Kaplan and Becker · 1996
  • K950815ChampionKleinfeld, Kaplan and Becker · 1995

All 2 as Kleinfeld, Kaplan and Becker →