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
Predicate lineage
- K101309
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
- EXTENSION SET MPS Pharma & Medical, Inc.
- Nexus TKO® NEXUS MEDICAL, LLC
- Nexus TKO® NEXUS MEDICAL, LLC
- Vial Adaptor WEST PHARMA. SERVICES IL, . LTD
- Vial Adaptor WEST PHARMA. SERVICES IL, . LTD
- "IV Administration Set, 10 mL, Non-Toxic, 83"" " Dynarex Corporation
- "IV Administration Set, 15 mL, Non-Toxic, 15-Drops /mL, 92"" (234.7 cm)" Dynarex Corporation
- "IV Administration Set, 15 mL, Non-Toxic, 73"" (185.4 cm)" Dynarex Corporation
- "IV Administration Set, 20 mL, Non-Toxic, 20-Drops/ mL 83"" (210.8 cm) " Dynarex Corporation
- "IV Administration Set, 20 mL, Non-Toxic, 20-Drops/mL, 100"" (254.0 cm) " Dynarex Corporation
- "IV Administration Set, 20 mL, Non-Toxic, 92"" (233.7 cm)" Dynarex Corporation
- "IV Administration Set, 20 mL, Non-Toxic, 92"" (234.7 cm) , 20 Drops/mL " Dynarex Corporation
Select up to two to place side-by-side with this device.