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ABL80 SC80
Model 945-727 · Radiometer Medical ApS · DI 05700699457271
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
GLY — Oximeter To Measure Hemoglobin · Class II · 21 CFR 864.7500
JFP — Electrode, Ion Specific, Calcium · Class II · 21 CFR 862.1145
JGS — Electrode, Ion Specific, Sodium · Class II · 21 CFR 862.1665
JJI — Analyzer, Enzyme, For Clinical Use · Class I · 21 CFR 862.2500
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
6.46
2019-02
0
8.55
2019-03
0
5.94
2019-04
0
7.51
2019-05
0
7.06
2019-06
0
6.39
2019-07
0
8.99
2019-08
0
7.95
2019-09
0
6.62
2019-10
0
5.23
2019-11
0
5.89
2019-12
0
6.53
2020-01
0
7.28
2020-02
0
5.42
2020-03
0
6.65
2020-04
0
7.95
2020-05
0
6.58
2020-06
0
6.06
2020-07
0
5.42
2020-08
0
5.23
2020-09
0
6.88
2020-10
0
6.13
2020-11
0
7
2020-12
0
6.7
2021-01
0
7.76
2021-02
0
7.92
2021-03
0
8.32
2021-04
0
5.7
2021-05
0
4.63
2021-06
0
6.78
2021-07
0
5.16
2021-08
0
5.77
2021-09
0
5.62
2021-10
0
6.83
2021-11
0
5.81
2021-12
0
5.24
2022-01
0
4.55
2022-02
0
5.79
2022-03
0
7.35
2022-04
0
7.17
2022-05
0
7.84
2022-06
0
5.35
2022-07
0
4.96
2022-08
0
6.52
2022-09
0
9.06
2022-10
0
9.29
2022-11
0
5.35
2022-12
0
6.51
2023-01
0
9.64
2023-02
0
8.24
2023-03
0
11.81
2023-04
0
11.1
2023-05
0
9.58
2023-06
0
7.95
2023-07
0
13.45
2023-08
0
16.35
2023-09
0
19.04
2023-10
0
9.46
2023-11
0
13.13
2023-12
0
15.23
2024-01
0
16.75
2024-02
0
14.43
2024-03
0
13.72
2024-04
0
10.63
2024-05
0
11.59
2024-06
0
10.24
2024-07
0
13.46
2024-08
0
13.74
2024-09
0
19.78
2024-10
0
17.69
2024-11
0
17.09
2024-12
0
10.46
2025-01
0
15.45
2025-02
0
11.04
2025-03
0
18.17
2025-04
0
11.97
2025-05
0
11.28
2025-06
0
6.73
2025-07
0
9.8
2025-08
0
6.22
2025-09
0
6.48
2025-10
0
8.81
2025-11
0
5.7
2025-12
0
6.73
2026-01
0
8.52
2026-02
0
7.55
2026-03
0
11.23
2026-04
0
20.92
2026-05
0
10.55
2026-06
0
9.4
This device (reports/month)Average device in CEM, CGA, CGZ, CHL, DQA, GHS, GKR, GLY, JFP, JGS, JJI, 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