BAYER RAPIDPOINT 400 SYSTEM— 510(k) K002738
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K002738 for BAYER RAPIDPOINT 400 SYSTEM, Substantially Equivalent on 2000-12-19. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code CHL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1120
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code CHL
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- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K002738
K-number listed on FDA's recall record- Z-2230-2025 — RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
- Z-2912-2016 — Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
- Z-2797-2016 — Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
- Z-2479-2015 — RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
- Z-0102-2014 — 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 hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002738.
Data sourced from openFDA. This site is unofficial and independent of the FDA.