epoc Blood Analysis System— 510(k) K200107
Substantially EquivalentEpocal, Inc.
FDA 510(k) clearance K200107 for epoc Blood Analysis System, Substantially Equivalent on 2020-06-05. Applicant: Epocal, Inc.. Device class: 2.
Clearance details
- Applicant
- Epocal, 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
- Ottawa, CA
Recent devices under product code CHL
view allMore clearances from Epocal, Inc.
view all- K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
- K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST
- K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
- K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
- K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
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 K200107
K-number listed on FDA's recall record- Z-2005-2026 — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
- Z-2272-2025 — epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
- Z-1684-2025 — 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 & 4.14.11, Sensor Configuration 45.n.
- Z-1685-2025 — 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 & 4.14.11, Sensor Configuration 45.n.
- Z-0734-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0735-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0736-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0737-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0738-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0739-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0740-2025 — 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 quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0741-2025 — 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 testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
- Z-0286-2025 — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
- Z-0601-2024 — 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 versions from 4.9.4 to the current version 4.11.11
- Z-2476-2023 — epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Z-2477-2023 — epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Z-2478-2023 — epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Z-1215-2023 — 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 11413518 epoc NXS Host, China-Korea 11413583
- Z-2970-2020 — 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 point of care SMN#/Model #: 10736382
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200107.
Data sourced from openFDA. This site is unofficial and independent of the FDA.