510(k) Report

FDA applicant

Cma Microdialysis AB

North Chelmsford, MA4 decisions2002–20110 recalls

FDA records 4 decisions for Cma Microdialysis AB (North Chelmsford, MA) from 2002 to 2011: 4 510(k) clearances. All are in product code GWM (Device, Monitoring, Intracranial Pressure). Its devices cite 6 predicates, 4 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, neurology panel, where it files most

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

FDA decisions per year

1in 2011

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cma Microdialysis AB 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?

  • GWMDevice, Monitoring, Intracranial Pressure4decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 20022cite it
  • K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 20061cites it
  • K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 20081cites it

What has FDA decided for it lately?

  • K102077Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2011
  • K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2008
  • K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2006
  • K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2002

All 4 as Cma Microdialysis AB →