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10815212026987
Model 525-620 · Izi Medical Products, LLC · DI 10815212026987
HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-06 · 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
12.92
2019-02
0
14.35
2019-03
0
14.05
2019-04
0
18.63
2019-05
0
19.54
2019-06
0
20.19
2019-07
0
13.37
2019-08
0
11.15
2019-09
0
11.95
2019-10
0
9.58
2019-11
0
11.88
2019-12
0
14.46
2020-01
0
11.27
2020-02
0
12.22
2020-03
0
12.88
2020-04
0
10.44
2020-05
0
15.5
2020-06
0
12.21
2020-07
0
14.34
2020-08
0
12.98
2020-09
0
12.31
2020-10
0
12.61
2020-11
0
14.12
2020-12
0
12.64
2021-01
0
11.89
2021-02
0
14.14
2021-03
0
13.25
2021-04
0
13.21
2021-05
0
14.8
2021-06
0
18.26
2021-07
0
13.79
2021-08
0
17.29
2021-09
0
24.68
2021-10
0
14.32
2021-11
0
16.72
2021-12
0
12.67
2022-01
0
10.59
2022-02
0
13.53
2022-03
0
15.09
2022-04
0
12.75
2022-05
0
16.55
2022-06
0
15.68
2022-07
0
12.74
2022-08
0
13.73
2022-09
0
15.67
2022-10
0
18.18
2022-11
0
16.94
2022-12
0
16.56
2023-01
0
14
2023-02
0
12.62
2023-03
0
16.68
2023-04
0
14.38
2023-05
0
16.67
2023-06
0
24.22
2023-07
0
25.39
2023-08
0
21.23
2023-09
0
17.03
2023-10
0
17.29
2023-11
0
18.43
2023-12
0
20.54
2024-01
0
25.65
2024-02
0
20.49
2024-03
0
21.69
2024-04
0
22.32
2024-05
0
18.44
2024-06
0
19.81
2024-07
0
23.6
2024-08
0
29.73
2024-09
0
22.75
2024-10
0
27.4
2024-11
0
14.37
2024-12
0
16.74
2025-01
0
16.27
2025-02
0
21.38
2025-03
0
25.24
2025-04
0
23.34
2025-05
0
20.44
2025-06
0
33.41
2025-07
0
20.35
2025-08
0
17.63
2025-09
0
19.99
2025-10
0
18.6
2025-11
0
16.83
2025-12
0
15.93
2026-01
0
17
2026-02
0
14.12
2026-03
0
15.06
2026-04
0
11.52
2026-05
0
11.51
2026-06
0
8.95
This device (reports/month)Average device in HAW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K022074 — cited as predicate by K142344, K191012, K222355, K230130
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Izi Medical Products, LLC
VAI 2015-06-04 IZI Medical Products, LLC · 3 citations
VAI 2015-06-04 IZI Medical Products, LLC · 3 citations
VAI 2013-07-31 IZI Medical Products, LLC · 3 citations
VAI 2013-07-31 IZI Medical Products, LLC · 3 citations