510(k) Report

FDA applicant

Dpc Cirrus

Randolph, NJ2 decisions1997–199814 recalls

FDA records 2 decisions for Dpc Cirrus (Randolph, NJ) from 1997 to 1998: 2 510(k) clearances. Most are in product codes DHX (System, Test, Carcinoembryonic Antigen) and JJE (Analyzer, Chemistry (Photometric, Discrete)…). 14 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Dpc Cirrus since 2007.

Recalls per year

2in 2020

2009: 32014: 22015: 52018: 12020: 2
2007high 5 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dpc Cirrus 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?

  • DHXSystem, Test, Carcinoembryonic Antigen1decision
  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K970227Immulite 2000 Automated Immunoassay AnalyzerDpc Cirrus · 19973cite it

What has FDA decided for it lately?

  • K980855Immulite 2000 Carcinoembryonic Antigen (Cea) KitDpc Cirrus · 19981 recall
  • K970227Immulite 2000 Automated Immunoassay AnalyzerDpc Cirrus · 199713 recalls

All 2 as Dpc Cirrus →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K970227Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 -…May 15, 2020Class II
  • K970227Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214…May 15, 2020Class II
  • K980855IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEAJan 2, 2018Class II
  • K970227Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are…Mar 5, 2015Class II
  • K970227Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous…Mar 5, 2015Class II
  • K970227Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are…Mar 5, 2015Class II