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AUXILIARY WATER INLET CAP
Model MAJ-215 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170071713
FDF — Colonoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
FDS — Gastroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
NWB — Endoscope, Accessories, Narrow Band Spectrum · Class II · 21 CFR 876.1500
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 (2)
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.
Malfunction: 2
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
3.06
2019-02
0
2.36
2019-03
0
3.94
2019-04
0
7.53
2019-05
0
3.29
2019-06
0
3.32
2019-07
0
4.44
2019-08
0
2.58
2019-09
0
2.56
2019-10
0
2.85
2019-11
0
2.95
2019-12
0
2.7
2020-01
0
2.3
2020-02
0
4.2
2020-03
0
2.8
2020-04
0
2.68
2020-05
0
5.11
2020-06
0
3.26
2020-07
0
6.28
2020-08
0
4.69
2020-09
0
4.72
2020-10
0
5.67
2020-11
0
5.97
2020-12
0
8.33
2021-01
0
8.44
2021-02
0
9.38
2021-03
0
10.53
2021-04
0
10.03
2021-05
0
9.13
2021-06
0
8.11
2021-07
0
8.45
2021-08
0
8.36
2021-09
0
10.86
2021-10
0
8.15
2021-11
0
9.29
2021-12
0
11.03
2022-01
0
9.56
2022-02
0
11.81
2022-03
0
12.61
2022-04
0
12.9
2022-05
0
12.29
2022-06
0
13.02
2022-07
0
11.78
2022-08
1
12
2022-09
1
11.45
2022-10
0
11.59
2022-11
0
11.06
2022-12
0
11.5
2023-01
0
10.1
2023-02
0
10.23
2023-03
0
13.6
2023-04
0
12.75
2023-05
0
11.31
2023-06
0
10.96
2023-07
0
11.85
2023-08
0
12.63
2023-09
0
11.39
2023-10
0
12.83
2023-11
0
13.26
2023-12
0
12.02
2024-01
0
12.3
2024-02
0
12.88
2024-03
0
15.23
2024-04
0
12.34
2024-05
0
11.03
2024-06
0
12.18
2024-07
0
12.83
2024-08
0
10.77
2024-09
0
11.07
2024-10
0
14.46
2024-11
0
8.14
2024-12
0
6.41
2025-01
0
7.24
2025-02
0
6.8
2025-03
0
8.09
2025-04
0
8.32
2025-05
0
9.01
2025-06
0
9.32
2025-07
0
8.89
2025-08
0
10.37
2025-09
0
7.08
2025-10
0
13.49
2025-11
0
21.81
2025-12
0
43.15
2026-01
0
33.27
2026-02
0
20.08
2026-03
0
18.96
2026-04
0
27.11
2026-05
0
28.33
2026-06
0
28.29
This device (reports/month)Average device in FDF, FDS, NWB (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K131780 — cited as predicate by K192793, K222584, K222861, K231249, K232244, K250432
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — OLYMPUS MEDICAL SYSTEMS CORP.
Warning Letter 2022-12-12 Olympus Medical Systems Corporation
Warning Letter 2018-03-09 Olympus Medical Systems Corporation
OAI 2022-09-09 Olympus Medical Systems Corporation · 1 citations
OAI 2015-04-24 Olympus Medical Systems Corporation · 2 citations