510(k) K200107 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
epoc Blood Analysis System
| Applicant | Epocal, Inc., Ottawa, CA |
| Decision | Substantially Equivalent, Jun 5, 2020 |
| Received | Jan 17, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System;
Siemens Material Number (SMN): 10736515; Open, Classified |
CHL | None listed |
| Aug 5, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Open, Classified |
JGS | None listed |
| Apr 29, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4 Open, Classified |
CHL | None listed |
| Apr 29, 2025 | Siemens Healthcare Diagnostics Inc epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative te Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitati Open, Classified |
CHL | None listed |
| Dec 20, 2024 | Siemens Healthcare Diagnostics, Inc. epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t Open, Classified |
CHL | None listed |
| Nov 1, 2024 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 Open, Classified |
CHL | None listed |
| Dec 21, 2023 | Siemens Healthcare Diagnostics Inc epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software Open, Classified |
CHL | None listed |
| Aug 28, 2023 | Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 Open, Classified |
CHL | None listed |
| Aug 28, 2023 | Siemens Healthcare Diagnostics Inc epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 Open, Classified |
CHL | None listed |
| Aug 28, 2023 | Siemens Healthcare Diagnostics Inc epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 Open, Classified |
CHL | None listed |
| Mar 3, 2023 | Siemens Healthcare Diagnostics Inc epoc Host 2 as follows:
Product SMN
epoc NXS Host, US 11413475
epoc NXS Host, EU 11413497
epoc NXS Host, Japan 11413498
epoc NXS Host, Canada 11413506
epoc NXS Host, ROW 1 Open, Classified |
CHL | None listed |
| Aug 28, 2020 | Siemens Healthcare Diagnostics Inc Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.