Transonic Systems Inc
Ithaca, NY, US
TRANSONIC SYSTEMS, INC. appears in FDA device records in Ithaca, NY. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Transonic Systems Inc between 1988 and 2015. The busiest year on record is 2002, with 3. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1990 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | DPW | Substantially Equivalent | |
| K134051 | TRANSONIC ELSA SYSTEM | DXG | Substantially Equivalent | |
| K134035 | TRANSONIC HCM 103 SYSTEM | DXG | Substantially Equivalent | |
| K140017 | TRANSONIC HCM 102 SYSTEM | DXG | Substantially Equivalent | |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | DXG | Substantially Equivalent | |
| K112657 | AUREFLO MONITORING SYSTEM | DPW | Substantially Equivalent | |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | DXG | Substantially Equivalent | |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 | DPW | Substantially Equivalent | |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | MQS | Substantially Equivalent | |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | MQS | Substantially Equivalent | |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | DYG | Substantially Equivalent | |
| K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV | KOC | Substantially Equivalent | |
| K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | MQS | Substantially Equivalent | |
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | MQS | Substantially Equivalent | |
| K903633 | ADVANCE LASER FLOWMETER, ALF 21 | DPW | Substantially Equivalent | |
| K872048 | TRANSONIC FLOWMETER | DPW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1319030 | 1319030 | TRANSONIC SYSTEMS, INC. | 34 Dutch Mill Rd, ITHACA, NY 14850 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | The sterility of the device cannot be assured. There is a potential for an increased risk of infection. | Class II | Terminated | |
| Z-2729-2015 | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2728-2015 | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2727-2015 | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2726-2015 | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2725-2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2724-2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2723-2015 | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2722-2015 | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2721-2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-2720-2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively. | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Class II | Terminated | |
| Z-1295-2015 | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment. | Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output). | Class II | Terminated | |
| Z-1147-2013 | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain