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ABOUND®
Model 7770 · ASCENSIA DIABETES CARE US INC. · DI 40301937770515
FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · Class II · 21 CFR 878.4850
LFR — Glucose Dehydrogenase, Glucose · Class II · 21 CFR 862.1345
NBW — System, Test, Blood Glucose, Over The Counter · Class II · 21 CFR 862.1345
UDILibrary device dossier · generated 2026-09-15 · 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
11.78
2019-02
0
15.47
2019-03
0
17.1
2019-04
0
22.47
2019-05
0
20.74
2019-06
0
19.37
2019-07
0
20.3
2019-08
0
18.29
2019-09
0
16.16
2019-10
0
17.36
2019-11
0
12.64
2019-12
0
14.12
2020-01
0
16.02
2020-02
0
14.01
2020-03
0
15.7
2020-04
0
13.4
2020-05
0
17.74
2020-06
0
21.54
2020-07
0
13.86
2020-08
0
8.93
2020-09
0
15.59
2020-10
0
9.3
2020-11
0
13.54
2020-12
0
14.07
2021-01
0
13.62
2021-02
0
13.32
2021-03
0
13.98
2021-04
0
14.75
2021-05
0
13.6
2021-06
0
14.87
2021-07
0
19.75
2021-08
0
14.01
2021-09
0
15.38
2021-10
0
14.98
2021-11
0
13.59
2021-12
0
17.52
2022-01
0
13.25
2022-02
0
12.17
2022-03
0
14.22
2022-04
0
12.97
2022-05
0
12.94
2022-06
0
11.39
2022-07
0
11.79
2022-08
0
6.14
2022-09
0
6.8
2022-10
0
6.11
2022-11
0
10.03
2022-12
0
5.78
2023-01
0
10.8
2023-02
0
8.01
2023-03
0
7.37
2023-04
0
5.55
2023-05
0
22.04
2023-06
0
14.48
2023-07
0
8.54
2023-08
0
8.85
2023-09
0
4.8
2023-10
0
4.88
2023-11
0
3.9
2023-12
0
3.55
2024-01
0
7.07
2024-02
0
2.58
2024-03
0
6.78
2024-04
0
3.53
2024-05
0
5.92
2024-06
0
4.49
2024-07
0
3.06
2024-08
0
2.85
2024-09
0
3.44
2024-10
0
4.23
2024-11
0
2.63
2024-12
0
5.08
2025-01
0
5.59
2025-02
0
2.47
2025-03
0
2.67
2025-04
0
3.93
2025-05
0
4.96
2025-06
0
2.71
2025-07
0
2.65
2025-08
0
4.46
2025-09
0
2.68
2025-10
0
3.48
2025-11
0
3.37
2025-12
0
3.01
2026-01
0
4.25
2026-02
0
2.34
2026-03
0
4
2026-04
0
3.76
2026-05
0
3.29
2026-06
0
4.96
This device (reports/month)Average device in FMK, LFR, NBW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ASCENSIA DIABETES CARE US INC.
NAI 2017-08-07 Ascensia Diabetes Care US, Inc. · 0 citations