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50 Dario Blood Glucose Test Strip
Model 1024-05 · LABSTYLE INNOVATION LTD · DI 00850065006185
CGA — Glucose Oxidase, Glucose · Class II · 21 CFR 862.1345
UDILibrary device dossier · generated 2026-09-11 · 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
3.57
2019-02
0
4.7
2019-03
0
5
2019-04
0
9.67
2019-05
0
10.21
2019-06
0
7.88
2019-07
0
13.42
2019-08
0
8.24
2019-09
0
4.95
2019-10
0
4.25
2019-11
0
4.86
2019-12
0
4.13
2020-01
0
4.8
2020-02
0
4.47
2020-03
0
5.29
2020-04
0
5
2020-05
0
4.57
2020-06
0
5.33
2020-07
0
5.4
2020-08
0
3.48
2020-09
0
4.93
2020-10
0
3.5
2020-11
0
4.57
2020-12
0
3
2021-01
0
4.22
2021-02
0
4.18
2021-03
0
3.67
2021-04
0
2.13
2021-05
0
2.47
2021-06
0
4.07
2021-07
0
2.77
2021-08
0
3.82
2021-09
0
4.88
2021-10
0
4.67
2021-11
0
2.92
2021-12
0
2.54
2022-01
0
2.46
2022-02
0
3.33
2022-03
0
3.9
2022-04
0
5.1
2022-05
0
3.17
2022-06
0
2.94
2022-07
0
3.53
2022-08
0
3.75
2022-09
0
3.4
2022-10
0
3.92
2022-11
0
2.47
2022-12
0
2.93
2023-01
0
24.69
2023-02
0
2.24
2023-03
0
4.1
2023-04
0
3.86
2023-05
0
3.04
2023-06
0
2.64
2023-07
0
4.44
2023-08
0
5.85
2023-09
0
7.17
2023-10
0
2.61
2023-11
0
3.12
2023-12
0
2.38
2024-01
0
2.27
2024-02
0
4
2024-03
0
2.64
2024-04
0
4.71
2024-05
0
3.18
2024-06
0
3
2024-07
0
2.71
2024-08
0
3.33
2024-09
0
6.15
2024-10
0
3.63
2024-11
0
3.64
2024-12
0
3.08
2025-01
0
3.36
2025-02
0
3.25
2025-03
0
8.67
2025-04
0
5.6
2025-05
0
5.54
2025-06
0
3.24
2025-07
0
7.73
2025-08
0
2.8
2025-09
0
3.29
2025-10
0
3.27
2025-11
0
2.21
2025-12
0
2.1
2026-01
0
3.91
2026-02
0
2.8
2026-03
0
6.13
2026-04
0
5.92
2026-05
0
3.71
2026-06
0
3.88
This device (reports/month)Average device in CGA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K150817 — cites (transitively): K131230 (d1), K103544 (d2) — cited as predicate by K163159, K172723
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LABSTYLE INNOVATION LTD