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"3.5"" X 10"" PRACTICON STERILIZATION POUCHES"
Model 7158234 · PRACTICON, INC. · DI 00723896026397
FRG — Wrap, Sterilization · Class II · 21 CFR 880.6850
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)
2019-04
0
3
2019-05
0
10
2019-06
0
4
2019-09
0
4
2019-11
0
2
2020-01
0
1
2020-02
0
3
2020-05
0
2
2020-12
0
28
2021-03
0
2
2021-05
0
3
2021-06
0
3.5
2021-09
0
2.5
2021-11
0
3
2022-08
0
6
2022-10
0
3
2023-05
0
3.25
2023-06
0
2
2023-07
0
1.5
2023-08
0
1
2023-09
0
2
2023-11
0
25
2023-12
0
9.5
2024-01
0
1
2024-02
0
2
2024-04
0
2
2024-05
0
1.5
2024-06
0
6.25
2024-07
0
2
2024-09
0
3
2024-11
0
3
2025-01
0
24
2025-02
0
3
2025-03
0
2.5
2025-04
0
4.33
2025-05
0
3.33
2025-06
0
9.2
2025-08
0
7.5
2025-10
0
1.67
2025-11
0
6
2025-12
0
1.5
2026-01
0
2.29
2026-02
0
3
2026-05
0
2.67
2026-06
0
3.5
This device (reports/month)Average device in FRG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K162258 — cites (transitively): K143637 (d1), K102158 (d2), K070428 (d3) — cited as predicate by K183356
Lineage extracted from public 510(k) summary text (heuristic).