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Cardea SOLO
Model C300/D300 · CARDIAC INSIGHT, INC. · DI 10857553006129
DQK — Computer, Diagnostic, Programmable · Class II · 21 CFR 870.1425
DSH — Recorder, Magnetic Tape, Medical · Class II · 21 CFR 870.2800
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)
2019-01
0
4.1
2019-02
0
1.83
2019-03
0
6.43
2019-04
0
3.91
2019-05
0
4
2019-06
0
4.4
2019-07
0
3.44
2019-08
0
3
2019-09
0
3.75
2019-10
0
3.47
2019-11
0
2.47
2019-12
0
2.93
2020-01
0
6
2020-02
0
3.79
2020-03
0
6
2020-04
0
4
2020-05
0
2.89
2020-06
0
3.23
2020-07
0
3.83
2020-08
0
3.73
2020-09
0
4.73
2020-10
0
3.5
2020-11
0
4.92
2020-12
0
5.45
2021-01
0
4.17
2021-02
0
4.08
2021-03
0
4.55
2021-04
0
5.07
2021-05
0
9.08
2021-06
0
5.42
2021-07
0
4.06
2021-08
0
6.82
2021-09
0
4.25
2021-10
0
2.63
2021-11
0
3.33
2021-12
0
4.5
2022-01
0
4.6
2022-02
0
4.82
2022-03
0
4.67
2022-04
0
3.82
2022-05
0
3.1
2022-06
0
2.82
2022-07
0
2.71
2022-08
0
2.19
2022-09
0
3.53
2022-10
0
3.25
2022-11
0
2.4
2022-12
0
3.54
2023-01
0
3.3
2023-02
0
3.76
2023-03
0
3.38
2023-04
0
2.69
2023-05
0
3.22
2023-06
0
3.71
2023-07
0
2.31
2023-08
0
2.6
2023-09
0
2.62
2023-10
0
2.27
2023-11
0
4.73
2023-12
0
10.35
2024-01
0
5.57
2024-02
0
7.93
2024-03
0
6.3
2024-04
0
8.28
2024-05
0
8.27
2024-06
0
10.71
2024-07
0
3.19
2024-08
0
5.05
2024-09
0
5.5
2024-10
0
4.42
2024-11
0
4.62
2024-12
0
3.08
2025-01
0
4.91
2025-02
0
4.2
2025-03
0
3.96
2025-04
0
5.17
2025-05
0
6.25
2025-06
0
2.69
2025-07
0
5.17
2025-08
0
4.76
2025-09
0
4.24
2025-10
0
3.5
2025-11
0
4.55
2025-12
0
5.19
2026-01
0
5.31
2026-02
0
6.25
2026-03
0
3.76
2026-04
0
5.63
2026-05
0
3.86
2026-06
0
2.35
This device (reports/month)Average device in DQK, DSH (reports/device/month)
Regulatory clearances
K162503 SESE 2017-03-24 (k number procode)
Predicate lineage
K162503 — cited as predicate by K231620
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CARDIAC INSIGHT, INC.
VAI 2025-02-07 Cardiac Insight, Inc. · 2 citations
VAI 2025-02-07 Cardiac Insight, Inc. · 2 citations
VAI 2017-02-10 Cardiac Insight, Inc. · 2 citations
VAI 2017-02-10 Cardiac Insight, Inc. · 2 citations
NAI 2014-05-09 Cardiac Insight, Inc. · 0 citations
NAI 2014-05-09 Cardiac Insight, Inc. · 0 citations