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inCourage®
Model 100030-008 · Respiratory Technologies, Inc. · DI 00841561100712
BYI — Percussor, Powered-Electric · Class II · 21 CFR 868.5665
UDILibrary device dossier · generated 2026-09-07 · 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)
2019-12
0
1
2020-08
0
1
2021-02
0
2
2021-03
0
1
2021-04
0
2
2021-05
0
1.5
2021-09
0
1
2021-12
0
1
2022-01
0
1
2022-03
0
1
2022-04
0
1
2022-07
0
1
2022-09
0
1
2022-11
0
1
2022-12
0
1
2023-01
0
3
2023-02
0
1
2023-04
0
1
2023-07
0
1
2023-08
0
2
2023-10
0
1.33
2023-11
0
1
2024-01
0
1
2024-02
0
1
2024-04
0
1
2024-05
0
1
2024-06
0
1
2024-08
0
1.2
2024-09
0
1.17
2024-10
0
2
2024-11
0
1
2025-01
0
1
2025-02
0
1
2025-03
0
1
2025-04
0
1.5
2025-05
0
2
2025-06
0
1
2025-07
0
1.25
2025-08
0
1.67
2025-09
0
1
2025-10
0
1.14
2025-11
0
1
2025-12
0
1.5
2026-01
0
2.5
2026-02
0
1.67
2026-03
0
1.67
2026-04
0
1.5
2026-05
0
1
2026-06
0
2
This device (reports/month)Average device in BYI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K051383 — cited as predicate by K092721
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Respiratory Technologies, Inc.
NAI 2014-10-09 Respiratory Technologies, Inc. · 2 citations
NAI 2011-11-17 Respiratory Technologies, Inc. · 2 citations
VAI 2010-06-18 Respiratory Technologies, Inc. · 0 citations