510(k) K002738 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
BAYER RAPIDPOINT 400 SYSTEM
| Applicant | Bayer Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Dec 19, 2000 |
| Received | Sep 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2025 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Open, Classified |
CHL | None listed |
| Sep 30, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 400 Measurement Cartridge
Siemens SMN numbers:10329756, 10341161 Terminated |
JFS | None listed |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 400 Blood Gas Analyzer
Siemens Material Number (SMN):
10291507,10314585, 10318899,10321239,10322654,10324081,
10328803, 10331381 , 10339634 Terminated |
CHL | None listed |
| Aug 28, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Blood Gas Analyzer,
Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306
This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin de Terminated |
KHP | None listed |
| Oct 29, 2013 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 400 system blood gas analyzer
Product Usage:
These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hem Terminated |
CHL | None listed |
| Mar 8, 2010 | Siemens Healthcare Diagnostics Inc RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites
Software Versions prior to 3.5.1.
The Siemens 400 series system is intended for point of care and laboratory testing of blood gase Terminated |
CHL | None listed |
| Mar 8, 2010 | Siemens Healthcare Diagnostics Inc RapidPoint 405 System Analyzers
The RP405 is capable of testing all of the analytes listed below including Co-Oximetry.
The Siemens 400 series system is intended for point of care and laboratory tes Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.