510(k) Report

FDA applicant

Karmelsonix

Binyamina, IL4 decisions2007–20110 recalls

FDA records 4 decisions for Karmelsonix (Binyamina, IL) from 2007 to 2011: 4 510(k) clearances. Most are in product codes BZM (Calculator, Pulmonary Function Interpretor…) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 7 predicates, 3 of them its own earlier devices. 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, anesthesiology panel, where it files most

How often FDA has decided Karmelsonix’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12009: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Karmelsonix 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?

  • BZMCalculator, Pulmonary Function Interpretor (Diagnostic)3decisions
  • DSHRecorder, Magnetic Tape, Medical1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K071955Wim-PC, Model 1010Karmelsonix · 20073cite it
  • K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 20101cites it
  • K090863Personal WheezometerKarmelsonix · 20091cites it

What has FDA decided for it lately?

  • K102229Pulmotrack 2020 SystemKarmelsonix · 2011
  • K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
  • K090863Personal WheezometerKarmelsonix · 2009
  • K071955Wim-PC, Model 1010Karmelsonix · 2007

All 4 as Karmelsonix →