510(k) Report

FDA applicant

Oridion Capnography, Inc.

Jerusalem, IL5 decisions2006–201112 recalls

FDA records 5 decisions for Oridion Capnography, Inc. (Jerusalem, IL) from 2006 to 2011: 5 510(k) clearances. Most are in product codes DQA (Oximeter) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 11 predicates, 4 of them its own earlier devices. 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Oridion Capnography, Inc.’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

9in 2018

2007: 22009: 12018: 9
2007high 9 (2018) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Oridion Capnography, Inc.’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?

  • DQAOximeter4decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 4 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.

  • K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 20108cite it
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 20067cite it
  • K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 20093cite it
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 20073cite it
  • K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 20111cites it

What has FDA decided for it lately?

  • K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 2011
  • K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
  • K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 20099 recalls
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 20063 recalls

All 5 as Oridion Capnography, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K082268CAPNOSTREAM 20 (US) N, Part Number CS08651Jul 31, 2018Class II
  • K082268Capnostream20 (US) M, Part Number CS08653Jul 31, 2018Class II
  • K082268Capnostream20 (US) M TO MASIMO, Part Number CS08750Jul 31, 2018Class II
  • K082268Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659Jul 31, 2018Class II
  • K082268CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657Jul 31, 2018Class II
  • K082268Capnostream20 (US)M REFURBISHED, Part Number CS78653Jul 31, 2018Class II

Other applicant names beginning “Oridion”

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

Oridion Medical 1987, Ltd. 19Oridion Medical, Ltd. 4Oridion, Ltd. 1