510(k) Report

FDA applicant

Clinical Micro Sensors, Inc.

Pasadena, CA3 decisions2006–20120 recalls

FDA records 3 decisions for Clinical Micro Sensors, Inc. (Pasadena, CA) from 2006 to 2012: 3 510(k) clearances. Most are in product codes NUA (System, Cystic Fibrosis Transmembrane…) and JJH (Clinical Sample Concentrator). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Clinical Micro Sensors”.

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

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

How often FDA has decided Clinical Micro Sensors, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clinical Micro Sensors, 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?

  • NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2decisions
  • JJHClinical Sample Concentrator1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800Clinical Micro Sensors · 20062cite it
  • K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 20061cites it

What has FDA decided for it lately?

  • K113731Esensor Respiratory Viral PanelClinical Micro Sensors, Inc. · 2012
  • K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006
  • K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800Clinical Micro Sensors · 2006

All 2 as Clinical Micro Sensors, Inc. →The one decision as Clinical Micro Sensors →