Skip to content
Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K223497Substantially equivalent (SESE) · 2023-02-17clearance family

Predicate lineage

Cited as predicate by: K240797

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

Similar devices
  • BIOER Sample Preservative Fluid Hangzhou Bioer Technology Co., Ltd.
  • BioSci™ Shenzhen Dakewe Bio-engineering Co., Ltd
  • BioSci™ Shenzhen Dakewe Bio-engineering Co., Ltd
  • BioSci™ Shenzhen Dakewe Bio-engineering Co., Ltd
  • DTPM Shenzhen Dakewe Bio-engineering Co., Ltd
  • DTPM Shenzhen Dakewe Bio-engineering Co., Ltd
  • Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd
  • Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd
  • Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd
  • Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd
  • Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd
  • Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd
Select up to two to place side-by-side with this device.