Data / Medical devices / United States / Transonic Systems, Inc.
Transonic Systems, Inc.: FDA-registered device maker in Ithaca, NY, United States, 5 510(k) clearances
Transonic Systems, Inc. is registered with the FDA (registration 1319030) in Ithaca, NY, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 29, 2015. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1319030
- Address
- 34 Dutch Mill Rd, Ithaca, NY, United States, 14850
- Owner or operator
- TRANSONIC SYSTEMS, INC. (1319030)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- AureFlo Monitoring System, HD01 Hemodialysis Monitor, HD02 Hemodialysis Monitor, HD02-E Hemodialysis Monitor, HD03 Hemdialysis Monitor, HT300 Series Transit Time Flowmeter, Hemodialysis Monitor, Transonic ELSA System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | 2 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
| System, Hemodialysis, Access Recirculation Monitoring | MQS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2015 | K134051 | TRANSONIC ELSA SYSTEM | DXG | Substantially Equivalent | Transonic Systems, Inc. | accessdata.fda.gov |
| December 21, 2011 | K112657 | AUREFLO MONITORING SYSTEM | DPW | Substantially Equivalent | Transonic Systems, Inc. | accessdata.fda.gov |
| October 6, 1998 | K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | MQS | Substantially Equivalent | Transonic Systems, Inc. | accessdata.fda.gov |
| February 11, 1997 | K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | MQS | Substantially Equivalent | Transonic Systems, Inc. | accessdata.fda.gov |
| June 21, 1988 | K872048 | TRANSONIC FLOWMETER | DPW | Substantially Equivalent | Transonic Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 15, 2018 | 79750 | Class II | Terminated | 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 flo | The sterility of the device cannot be assured. There is a potential for an increased risk of infection. | accessdata.fda.gov |
| July 27, 2015 | 71907 | Class II | Terminated | 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. | accessdata.fda.gov |
| February 17, 2015 | 70647 | Class II | Terminated | 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 | 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). | accessdata.fda.gov |
| March 28, 2013 | 64770 | Class II | Terminated | 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 wi | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | accessdata.fda.gov |
Compare with other makers
- All makers of Flowmeter, Blood, Cardiovascular
- All makers of Computer, Diagnostic, Pre-Programmed, Single-Function
Updated January 29, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.