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925-047 ABL90 FLEX inlet clip
Model 925-047 · Radiometer Medical ApS · DI 05700699250476
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
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
KHP — Acid, Lactic, Enzymatic Method · Class I · 21 CFR 862.1450
KQI — Assay, Fetal Hemoglobin · Class II · 21 CFR 864.7455
MQM — Bilirubin (Total And Unbound) In The Neonate Test System · Class I · 21 CFR 862.1113
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
2.66
2019-02
0
4.66
2019-03
0
2.6
2019-04
0
4.5
2019-05
0
5.02
2019-06
0
5.56
2019-07
0
10.16
2019-08
0
6.28
2019-09
0
3.06
2019-10
0
3.12
2019-11
0
3.11
2019-12
0
4.38
2020-01
0
4.61
2020-02
0
2.67
2020-03
0
5.32
2020-04
0
3.63
2020-05
0
4.3
2020-06
0
4.5
2020-07
0
3.68
2020-08
0
3.54
2020-09
0
3.98
2020-10
0
2.65
2020-11
0
3.59
2020-12
0
1.85
2021-01
0
3.03
2021-02
0
4.02
2021-03
0
3.83
2021-04
0
2.3
2021-05
0
2.19
2021-06
0
4.53
2021-07
0
2.37
2021-08
0
3.64
2021-09
0
4.67
2021-10
0
5.64
2021-11
0
3.02
2021-12
0
2.65
2022-01
0
2.71
2022-02
0
4.01
2022-03
0
4.59
2022-04
0
5.05
2022-05
0
2.81
2022-06
0
2.45
2022-07
0
3.22
2022-08
0
3.71
2022-09
0
3.14
2022-10
0
3.62
2022-11
0
2.05
2022-12
0
3.19
2023-01
0
8.02
2023-02
0
2.45
2023-03
0
4.96
2023-04
0
4.43
2023-05
0
3.3
2023-06
0
2.41
2023-07
0
4.82
2023-08
0
4.92
2023-09
0
7.56
2023-10
0
2.99
2023-11
0
3.59
2023-12
0
2.49
2024-01
0
3.06
2024-02
0
4.24
2024-03
0
3.77
2024-04
0
4.91
2024-05
0
4.79
2024-06
0
5.11
2024-07
0
3.88
2024-08
0
4.92
2024-09
0
11.26
2024-10
0
3.98
2024-11
0
4.78
2024-12
0
3.98
2025-01
0
4.54
2025-02
0
4.17
2025-03
0
13.92
2025-04
0
7.45
2025-05
0
9.43
2025-06
0
4.77
2025-07
0
10.77
2025-08
0
4.45
2025-09
0
5.02
2025-10
0
4.82
2025-11
0
3
2025-12
0
2.96
2026-01
0
6.33
2026-02
0
3.91
2026-03
0
12.94
2026-04
0
9.42
2026-05
0
5.68
2026-06
0
5.28
This device (reports/month)Average device in CEM, CGA, CGZ, CHL, GHS, GKR, JFP, JGS, JIX, JJY, KHP, KQI, MQM (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