Print-ready dossier — use your browser's print dialog to save as PDF.
IV Catheter Dressings
Model 4609 · Dynarex Corporation · DI 00616784460918
KMK — Device, Intravascular Catheter Securement · Class I · 21 CFR 880.5210
NAD — Dressing, Wound, Occlusive · Class I · 21 CFR 878.4020
UDILibrary device dossier · generated 2026-09-15 · 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
1
2019-02
0
1.5
2019-03
0
1
2019-04
0
1.8
2019-05
0
1
2019-06
0
1.8
2019-07
0
3
2019-08
0
2.67
2019-09
0
1
2019-10
0
1.75
2019-11
0
1.25
2020-01
0
2.67
2020-02
0
1.75
2020-03
0
4.67
2020-04
0
1.6
2020-05
0
1
2020-06
0
2.17
2020-07
0
4.2
2020-08
0
2.33
2020-09
0
5.9
2020-10
0
5.56
2020-11
0
6.29
2020-12
0
20.45
2021-01
0
5.17
2021-02
0
4
2021-03
0
5.27
2021-04
0
15
2021-05
0
2.6
2021-06
0
2
2021-08
0
3.6
2021-09
0
3
2021-10
0
8
2021-11
0
3.33
2021-12
0
1
2022-01
0
3
2022-02
0
3
2022-03
0
2.88
2022-04
0
2
2022-05
0
2.6
2022-06
0
4.25
2022-07
0
3
2022-08
0
1.33
2022-09
0
23.25
2022-10
0
4
2022-11
0
4
2023-01
0
6
2023-02
0
2.25
2023-03
0
3
2023-04
0
2.71
2023-05
0
2
2023-06
0
5
2023-07
0
1.5
2023-08
0
4.4
2023-09
0
125
2023-10
0
194.75
2023-11
0
68
2023-12
0
7.75
2024-01
0
9
2024-02
0
13.8
2024-03
0
15
2024-04
0
5
2024-05
0
2.29
2024-06
0
8.67
2024-07
0
34.67
2024-08
0
4.5
2024-09
0
96.33
2024-10
0
22.38
2024-11
0
5.6
2024-12
0
3
2025-01
0
44.33
2025-02
0
152.67
2025-03
0
19.2
2025-04
0
2.25
2025-05
0
19.58
2025-06
0
20.71
2025-07
0
9.8
2025-08
0
8.3
2025-09
0
34.9
2025-10
0
6.43
2025-11
0
28.4
2025-12
0
26.67
2026-01
0
29.89
2026-02
0
8.86
2026-03
0
6.33
2026-04
0
40.8
2026-05
0
8.43
2026-06
0
3.25
This device (reports/month)Average device in KMK, NAD (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Dynarex Corporation