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Change over valve
Model 077.0561 · Medela AG · DI 07612367003575
BTA — Pump, Portable, Aspiration (Manual Or Powered) · Class II · 21 CFR 878.4780
GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered · Class II · 21 CFR 880.6740
HDB — Extractor, Vacuum, Fetal · Class II · 21 CFR 884.4340
QPB — System, Suction, Lipoplasty For Removal · Class II · 21 CFR 878.5040
UDILibrary device dossier · generated 2026-09-13 · 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
1.67
2019-02
0
3.8
2019-03
0
2
2019-04
0
1.57
2019-05
0
1.78
2019-06
0
1.69
2019-07
0
2.14
2019-08
0
2.14
2019-09
0
1.57
2019-10
0
2.33
2019-11
0
4.36
2019-12
0
1.5
2020-01
0
3.29
2020-02
0
1.14
2020-03
0
1.9
2020-04
0
2.5
2020-05
0
2.33
2020-06
0
1.67
2020-07
0
3
2020-08
0
2
2020-09
0
2
2020-10
0
2.5
2020-11
0
2.43
2020-12
0
1.86
2021-01
0
1
2021-02
0
3.17
2021-03
0
2.57
2021-04
0
3.29
2021-05
0
3.2
2021-06
0
2.5
2021-07
0
2.5
2021-08
0
6.14
2021-09
0
11
2021-10
0
13.67
2021-11
0
4.56
2021-12
0
5
2022-01
0
3.1
2022-02
0
4.67
2022-03
0
5.86
2022-04
0
8
2022-05
0
2.55
2022-06
0
2.8
2022-07
0
1.82
2022-08
0
3.88
2022-09
0
4.33
2022-10
0
3
2022-11
0
5.89
2022-12
0
4.2
2023-01
0
6
2023-02
0
12.67
2023-03
0
11.77
2023-04
0
9.58
2023-05
0
7.64
2023-06
0
6.75
2023-07
0
5.45
2023-08
0
7.91
2023-09
0
7
2023-10
0
4.55
2023-11
0
10.22
2023-12
0
4.2
2024-01
0
4.62
2024-02
0
12.9
2024-03
0
5.77
2024-04
0
8.56
2024-05
0
11.89
2024-06
0
5.46
2024-07
0
9
2024-08
0
7
2024-09
0
9.71
2024-10
0
10.33
2024-11
0
8.56
2024-12
0
4.82
2025-01
0
5.8
2025-02
0
2.78
2025-03
0
6.93
2025-04
0
6.58
2025-05
0
7
2025-06
0
9.17
2025-07
0
6.78
2025-08
0
5.56
2025-09
0
3.08
2025-10
0
4.57
2025-11
0
5.45
2025-12
0
5.4
2026-01
0
3.89
2026-02
0
3.67
2026-03
0
6
2026-04
0
7.4
2026-05
0
6.7
2026-06
0
4.44
This device (reports/month)Average device in BTA, GCX, HDB, QPB (reports/device/month)