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ABL80 SC80
Model 945-690 · Radiometer Medical ApS · DI 05700699456908
CEM — Electrode, Ion Specific, Potassium · Class II · 21 CFR 862.1600
CGA — Glucose Oxidase, Glucose · Class II · 21 CFR 862.1345
CGZ — Electrode, Ion-Specific, Chloride · Class II · 21 CFR 862.1170
CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph · Class II · 21 CFR 862.1120
DQA — Oximeter · Class II · 21 CFR 870.2700
GHS — Assay, Carboxyhemoglobin · Class II · 21 CFR 864.7425
GKR — System, Hemoglobin, Automated · Class II · 21 CFR 864.5620
JFP — Electrode, Ion Specific, Calcium · Class II · 21 CFR 862.1145
JGS — Electrode, Ion Specific, Sodium · Class II · 21 CFR 862.1665
JIX — Calibrator, Multi-Analyte Mixture · Class II · 21 CFR 862.1150
JJY — Multi-Analyte Controls, All Kinds (Assayed) · Class I · 21 CFR 862.1660
JPI — Device, Hematocrit Measuring · Class II · 21 CFR 864.6400
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
6.32
2019-02
0
8.4
2019-03
0
5.79
2019-04
0
7.46
2019-05
0
6.92
2019-06
0
6.34
2019-07
0
9.04
2019-08
0
7.86
2019-09
0
6.51
2019-10
0
5.16
2019-11
0
5.77
2019-12
0
6.53
2020-01
0
7.13
2020-02
0
5.3
2020-03
0
6.64
2020-04
0
7.9
2020-05
0
6.48
2020-06
0
6.03
2020-07
0
5.39
2020-08
0
5.2
2020-09
0
6.79
2020-10
0
6.01
2020-11
0
6.93
2020-12
0
6.71
2021-01
0
7.63
2021-02
0
7.81
2021-03
0
8.15
2021-04
0
5.68
2021-05
0
4.6
2021-06
0
6.71
2021-07
0
5.13
2021-08
0
5.75
2021-09
0
5.65
2021-10
0
6.76
2021-11
0
5.73
2021-12
0
5.22
2022-01
0
4.49
2022-02
0
5.85
2022-03
0
7.22
2022-04
0
7.14
2022-05
0
7.7
2022-06
0
5.34
2022-07
0
4.9
2022-08
0
6.44
2022-09
0
8.89
2022-10
0
9.16
2022-11
0
5.32
2022-12
0
6.3
2023-01
0
9.5
2023-02
0
8.17
2023-03
0
11.6
2023-04
0
10.92
2023-05
0
9.42
2023-06
0
7.78
2023-07
0
13.27
2023-08
0
16.09
2023-09
0
18.91
2023-10
0
9.42
2023-11
0
13.02
2023-12
0
14.68
2024-01
0
16.57
2024-02
0
14.05
2024-03
0
13.51
2024-04
0
10.52
2024-05
0
11.6
2024-06
0
10.26
2024-07
0
13.21
2024-08
0
13.54
2024-09
0
19.7
2024-10
0
17.08
2024-11
0
16.83
2024-12
0
10.52
2025-01
0
15.24
2025-02
0
10.96
2025-03
0
18.52
2025-04
0
11.92
2025-05
0
11.42
2025-06
0
6.73
2025-07
0
10.05
2025-08
0
6.27
2025-09
0
6.6
2025-10
0
8.65
2025-11
0
5.64
2025-12
0
6.68
2026-01
0
8.63
2026-02
0
7.51
2026-03
0
11.67
2026-04
0
20.91
2026-05
0
10.51
2026-06
0
9.25
This device (reports/month)Average device in CEM, CGA, CGZ, CHL, DQA, GHS, GKR, JFP, JGS, JIX, JJY, JPI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Radiometer Medical ApS
NAI 2025-12-04 SenDx Medical, Inc. · 0 citations
NAI 2024-09-19 Radiometer Medical ApS · 0 citations
NAI 2024-09-19 Radiometer Medical ApS · 0 citations
NAI 2017-05-17 Radiometer Sp z.o.o. · 0 citations
NAI 2017-05-11 Radiometer Medical ApS · 0 citations
NAI 2017-05-11 Radiometer Medical ApS · 0 citations
VAI 2016-10-20 Radiometer Basel AG · 2 citations
VAI 2015-03-02 Radiometer America Inc · 4 citations
VAI 2011-08-18 Radiometer America Inc · 3 citations