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"ri-san® Manometer,Skale "" Karl-Storz"" Pres.,"
Model 1517-100.002 · Rudolf Riester GmbH · DI 04045396174221
DXQ — Blood Pressure Cuff · Class II · 21 CFR 870.1120
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)
2020-03
0
1
2020-10
0
1
2021-08
0
1
2021-10
0
2
2022-07
0
1
2022-12
0
1
2023-06
0
1
2023-11
0
5.5
2023-12
0
2.33
2024-01
0
1
2024-02
0
1
2024-03
0
1
2024-04
0
1
2024-05
0
25
2024-06
0
10
2024-07
0
12
2024-08
0
11
2024-09
0
1.5
2024-10
0
1
2024-11
0
1
2024-12
0
16
2025-02
0
5.5
2025-04
0
1
2025-05
0
4
2025-08
0
2.5
2025-09
0
2.5
2025-10
0
1.5
2025-11
0
6
2025-12
0
1
2026-01
0
1
2026-02
0
2.5
2026-03
0
1.67
2026-04
0
2
2026-05
0
2.33
2026-06
0
2.86
This device (reports/month)Average device in DXQ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K002954 — cited as predicate by K101892
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Rudolf Riester GmbH