RAPIDPoint 500e Blood Gas System— 510(k) K192240
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K192240 for RAPIDPoint 500e Blood Gas System, Substantially Equivalent on 2020-03-27. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 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
- Special
- Location
- Norowood, MA, US
Recent devices under product code CHL
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse 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 K192240
K-number listed on FDA's recall record- Z-2214-2024 — Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
- Z-0422-2024 — RAPIDPOINT 500e Blood Gas System
- Z-1372-2022 — epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
- Z-2432-2020 — RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192240.
Data sourced from openFDA. This site is unofficial and independent of the FDA.