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Adapter Vario
Model 077.0105 · Medela AG · DI 07612367015387
BTA — Pump, Portable, Aspiration (Manual Or Powered) · Class II · 21 CFR 878.4780
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)
2019-02
0
4.33
2019-03
0
2
2019-04
0
1.5
2019-05
0
2
2019-06
0
3.5
2019-07
0
3.33
2019-08
0
4
2019-09
0
1.5
2019-10
0
3
2019-11
0
13
2019-12
0
1
2020-01
0
3.6
2020-02
0
1
2020-03
0
1.5
2020-04
0
2.33
2020-05
0
1.5
2020-07
0
2
2020-08
0
3
2020-09
0
1
2020-10
0
4
2020-11
0
3
2020-12
0
4
2021-01
0
1
2021-03
0
4
2021-04
0
5
2021-05
0
3
2021-06
0
4
2021-07
0
3
2021-08
0
13
2021-09
0
25.5
2021-10
0
19.5
2021-11
0
12.5
2021-12
0
13.5
2022-01
0
6.25
2022-02
0
6.5
2022-03
0
17.5
2022-04
0
23
2022-05
0
6.5
2022-06
0
5
2022-07
0
3.67
2022-08
0
8.33
2022-09
0
14.5
2022-10
0
5.25
2022-11
0
21
2022-12
0
6.33
2023-01
0
11
2023-02
0
20
2023-03
0
20.57
2023-04
0
15.57
2023-05
0
14.2
2023-06
0
10.29
2023-07
0
7
2023-08
0
13.33
2023-09
0
7
2023-10
0
9.75
2023-11
0
12.71
2023-12
0
5.57
2024-01
0
8.8
2024-02
0
16.14
2024-03
0
9.71
2024-04
0
11.67
2024-05
0
13.25
2024-06
0
9.83
2024-07
0
11.29
2024-08
0
8
2024-09
0
15.25
2024-10
0
21.25
2024-11
0
16
2024-12
0
7
2025-01
0
10.2
2025-02
0
3.25
2025-03
0
7.63
2025-04
0
7.25
2025-05
0
6.89
2025-06
0
11.75
2025-07
0
12
2025-08
0
6.13
2025-09
0
3.57
2025-10
0
6.4
2025-11
0
7.33
2025-12
0
7.6
2026-01
0
5.33
2026-02
0
4.67
2026-03
0
10.6
2026-04
0
9.57
2026-05
0
6.5
2026-06
0
6.38
This device (reports/month)Average device in BTA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K153663 — cites (transitively): K061205 (d1), K061435 (d1) — cited as predicate by K153633, K221676
Lineage extracted from public 510(k) summary text (heuristic).