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Wondfo Key Cup
Model KDOA-274 · WONDFO USA CO., LTD. · DI 00816862025026
DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Class II · 21 CFR 862.3250
DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650
DKZ — Enzyme Immunoassay, Amphetamine · Class II · 21 CFR 862.3100
JXM — Enzyme Immunoassay, Benzodiazepine · Class II · 21 CFR 862.3170
LAF — Gas Chromatography, Methamphetamine · Class II · 21 CFR 862.3610
LDJ — Enzyme Immunoassay, Cannabinoids · Class II · 21 CFR 862.3870
UDILibrary device dossier · generated 2026-09-06 · 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
2019-05
0
1
2019-06
0
1
2019-07
0
1
2019-10
0
2
2019-12
0
1
2021-07
0
1
2021-11
0
1
2022-06
0
1
2023-03
0
2
2023-07
0
3.5
2024-01
0
1
2024-04
0
6
2024-10
0
2
2024-11
0
4
2025-01
0
2
2025-05
0
2
2025-07
0
2
2025-08
0
2
2025-10
0
1
2026-03
0
2
2026-04
0
1
2026-06
0
2
This device (reports/month)Average device in DIO, DJG, DKZ, JXM, LAF, LDJ (reports/device/month)
Regulatory clearances
K130665 SESE 2013-04-09 (k number procode)
Predicate lineage
K130665 — cited as predicate by K140089
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — WONDFO USA CO., LTD.