Data / Medical devices / Denmark / Radiometer Medical Aps
Radiometer Medical Aps: FDA-registered device maker in BROENSHOEJ Hovedstaden, Denmark, 21 510(k) clearances
Radiometer Medical Aps is registered with the FDA (registration 3002807968) in BROENSHOEJ Hovedstaden, Denmark. It lists 26 device types. The FDA files 21 510(k) clearances under its listings, the newest dated May 1, 2026. 18 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807968
- Address
- Aakandevej 21, BROENSHOEJ Hovedstaden, Denmark, 2700
- Owner or operator
- Radiometer Medical ApS (9064213)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 18, 2003
- Registered through
- 2026
- Brand names listed
- 944-519 S7620 QUALICHECK 7+, level 0, 944-520 S7630 QUALICHECK 7+, level 1, 944-521 S7640 QUALICHECK 7+, level 2, 944-522 S7650 QUALICHECK 7+, level 3, 944-523 S7660 QUALICHECK 7+, level 4, 956-533 PICO70 23Gx25 mm, ABL90 FLEX, ABL90 FLEX PLUS and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2026 | K252488 | ABL90 FLEX PLUS System | CGA | Substantially Equivalent | Radiometer Medicals Aps | accessdata.fda.gov |
| May 1, 2026 | K252475 | ABL90 FLEX PLUS System | JGS | Substantially Equivalent | Radiometer Medicals Aps | accessdata.fda.gov |
| April 10, 2026 | K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | CHL | Substantially Equivalent | Radiometer Medicals Aps | accessdata.fda.gov |
| January 14, 2025 | K241037 | ABL90 FLEX PLUS System | CEM | Substantially Equivalent | Radiometer Medicals Aps | accessdata.fda.gov |
| December 13, 2024 | K240998 | ABL90 FLEX PLUS System | CHL | Substantially Equivalent | Radiometer Medicals Aps | accessdata.fda.gov |
| November 4, 2016 | K160153 | ABL90 FLEX PLUS | CHL | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| May 13, 2015 | K150226 | Hematocrit and Metabolite QUALICHECK | JJS | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| November 13, 2014 | K132691 | ABL90 FLEX | MQM | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| March 26, 2013 | K130415 | HIGH METABOLITE QUALICHECK | JJS | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| March 15, 2013 | K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | JJS | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| August 6, 2010 | K092686 | ABL90 FLEX SERIES | CEM | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| February 5, 2010 | K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | LKD | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| October 16, 2006 | K051968 | ABL8X7 FLEX | CGL | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| October 12, 2005 | K051928 | AUTOCHECK6+ | JJY | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| April 22, 2005 | K043143 | SAFEPICO | JKA | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| March 1, 2005 | K043003 | TCM40 MONITORING SYSTEM | LKD | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| October 8, 2004 | K041874 | ABL800 FLEX | CHL | Substantially Equivalent | Radiometer Medical Aps | accessdata.fda.gov |
| December 7, 2000 | K001866 | TCM400 | LPP | Substantially Equivalent | Radiometer Medical A/S | accessdata.fda.gov |
| September 13, 2000 | K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) | CHL | Substantially Equivalent | Radiometer Medical A/S | accessdata.fda.gov |
| January 28, 1998 | K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | JJS | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
| October 29, 1996 | K962158 | PICO MODELS 30, 50, 70 | JKA | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 18, 2026 | 99772 | Class II | Ongoing | The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Th | In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings. | accessdata.fda.gov |
| March 21, 2025 | 96515 | Class II | Ongoing | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory envir | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even | accessdata.fda.gov |
| May 31, 2024 | 94771 | Class II | Ongoing | ABL800 FLEX Model Numbers and The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry pa | Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples. | accessdata.fda.gov |
| March 8, 2023 | 91917 | Class II | Ongoing | AQURE REF Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test | Due to potential software issue that may result in patient mix-up information. | accessdata.fda.gov |
| May 18, 2022 | 90286 | Class II | Ongoing | ABL800 Flex Analyzer Model Numbers and | There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. | accessdata.fda.gov |
| April 8, 2022 | 90093 | Class II | Ongoing | Radiometer, REF:, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection., IVD, Rx Only, Sterile EO, CE | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. | accessdata.fda.gov |
| April 14, 2021 | 87870 | Class II | Ongoing | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | accessdata.fda.gov |
| March 26, 2021 | 87867 | Class II | Terminated | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite a | Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of | accessdata.fda.gov |
| May 26, 2020 | 85700 | Class II | Terminated | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number; UDI (01)05700693938004. Model is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL | Potential risk of patient mix-up on analyzers due to software issues. | accessdata.fda.gov |
| May 11, 2020 | 85634 | Class II | Terminated | ABL80-FLEX-393-839 Box Label, REF, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up a | accessdata.fda.gov |
| March 17, 2020 | 85478 | Class II | Terminated | safeCLINITUBES Blood Sampler;REF;D957P-70-100x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. | accessdata.fda.gov |
| March 10, 2020 | 85168 | Class II | Terminated | ABL800 FLEX, model number/UDI /0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin | Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment | accessdata.fda.gov |
| March 6, 2020 | 85166 | Class II | Ongoing | ABL800 FLEX model number and, UDI:(01)05700693938004 | Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac | accessdata.fda.gov |
| February 20, 2020 | 85257 | Class II | Terminated | TCM4 Base unit, Ref, UDI:(01)05700693918808, used with the monitor modules TCM4 ), TCM40, or ), TCM400 ), TOSCA ) and CombiM ) - Product Usage: It is indicated for use on pediatrics and adults. | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance. | accessdata.fda.gov |
| February 3, 2020 | 85326 | Class II | Terminated | ABL90 FLEX Analyzer, Model Numbers, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment. | accessdata.fda.gov |
| November 21, 2019 | 85390 | Class II | Terminated | ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units ): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors | accessdata.fda.gov |
| August 8, 2019 | 84496 | Class II | Terminated | AQURE basic sytem, FLEXLINK, REF, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up. | accessdata.fda.gov |
| February 27, 2018 | 79411 | Class II | Terminated | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up. | accessdata.fda.gov |
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Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.