Dakewe
Model ITMT · Shenzhen Dakewe Bio-engineering Co., Ltd · DI 06973471960590
QBD — Microbial Nucleic Acid Storage And Stabilization Device · Class II · 21 CFR 866.2950
UDILibrary device dossier · generated 2026-09-16 · 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.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K220059 — cites (transitively): K201849 (d1), DEN170029 (d2)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Shenzhen Dakewe Bio-engineering Co., Ltd
Nothing in the loaded window.