Transonic Systems, Inc.

• DPW — Cardiovascular6 devices
• DXG — Cardiovascular5 devices
• MQS — Gastroenterology, Urology4 devices
• DYG — Cardiovascular1 device
• KOC — Gastroenterology, Urology1 device

• Z-1776-2018 — Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.Class II·Terminated·2018-02-15
• Z-2727-2015 — Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2724-2015 — Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2723-2015 — Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2720-2015 — Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2725-2015 — Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2729-2015 — Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2722-2015 — Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2726-2015 — Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27
• Z-2728-2015 — Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.Class II·Terminated·2015-07-27

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K261714 — FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and FlowsensorsProduct code DPW·2026-10-27
• K140740 — TRANSONIC TISSUE PERFUSION MONITORProduct code DPW·2015-07-23
• K134051 — TRANSONIC ELSA SYSTEMProduct code DXG·2015-01-29
• K134035 — TRANSONIC HCM 103 SYSTEMProduct code DXG·2014-09-17
• K140017 — TRANSONIC HCM 102 SYSTEMProduct code DXG·2014-09-16
• K113821 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMProduct code DXG·2012-09-07
• K112657 — AUREFLO MONITORING SYSTEMProduct code DPW·2011-12-21
• K080116 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMProduct code DXG·2008-09-08
• K033424 — ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002Product code DPW·2003-12-11
• K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000Product code MQS·2002-12-04
• K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010Product code MQS·2002-08-12
• K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101Product code DYG·2002-03-19
• K002816 — TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREVProduct code KOC·2000-11-22
• K980906 — TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-COProduct code MQS·1998-10-06
• K960817 — HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)Product code MQS·1997-02-11
• K903633 — ADVANCE LASER FLOWMETER, ALF 21Product code DPW·1990-10-09
• K872048 — TRANSONIC FLOWMETERProduct code DPW·1988-06-21