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Brevera Breast Biopsy System
Model BREV100 · Hologic, Inc. · DI 15420045507517
KNW — Instrument, Biopsy · Class II · 21 CFR 876.1075
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 (302)
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.
Injury: 213 · Malfunction: 89
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
11.13
2019-02
2
4.13
2019-03
0
2.6
2019-04
0
3.54
2019-05
0
7.38
2019-06
0
41.85
2019-07
0
9.24
2019-08
0
63.43
2019-09
0
30.31
2019-10
0
11.12
2019-11
0
33.61
2019-12
0
46.68
2020-01
0
42.17
2020-02
2
34.08
2020-03
0
137.06
2020-04
0
64.38
2020-05
0
33.55
2020-06
0
66.13
2020-07
0
57.25
2020-08
0
33.63
2020-09
0
40.24
2020-10
0
22.5
2020-11
2
28.13
2020-12
0
15.74
2021-01
0
20.28
2021-02
0
12.97
2021-03
0
12.7
2021-04
0
9.2
2021-05
0
4.29
2021-06
0
4.73
2021-07
0
5.88
2021-08
0
6.48
2021-09
0
10.65
2021-10
0
5.43
2021-11
0
4.23
2021-12
0
7.62
2022-01
0
6.9
2022-02
0
8.39
2022-03
0
5.7
2022-04
0
3.76
2022-05
0
3
2022-06
2
2.68
2022-07
3
3.74
2022-08
27
3.95
2022-09
14
5.42
2022-10
25
5.95
2022-11
0
3.96
2022-12
4
5.74
2023-01
8
3.73
2023-02
6
6.29
2023-03
21
5.15
2023-04
9
6.26
2023-05
9
5.15
2023-06
12
5.86
2023-07
9
4.95
2023-08
3
5.79
2023-09
3
4.77
2023-10
3
8.78
2023-11
3
7.22
2023-12
3
7.63
2024-01
9
9.97
2024-02
8
5.16
2024-03
0
4.15
2024-04
3
7.54
2024-05
3
5.44
2024-06
0
11.85
2024-07
0
6.11
2024-08
3
10.25
2024-09
2
13.25
2024-10
12
6.5
2024-11
0
4.24
2024-12
12
5.88
2025-01
3
4.57
2025-02
3
6.66
2025-03
7
11.29
2025-04
0
8.63
2025-05
12
8.45
2025-06
12
6.93
2025-07
6
6.06
2025-08
8
12.38
2025-09
3
6.9
2025-10
11
5.83
2025-11
6
8.5
2025-12
3
9.26
2026-01
6
15.75
2026-02
0
16.68
2026-03
0
11.69
2026-04
0
15.03
2026-05
0
15.8
2026-06
0
23.48
This device (reports/month)Average device in KNW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K163052 — cites (transitively): K042290 (d1), K111508 (d1), K061361 (d2) — cited as predicate by K252681
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Hologic, Inc.
Warning Letter 2024-12-18 Hologic, Inc
Warning Letter 2024-12-18 Hologic, Inc
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
VAI 2024-09-12 Hologic Surgical Products Costa Rica, S.R.L. · 0 citations