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Transonic Systems Inc.

United States·US-MF-000008784

Last updated September 18, 2026

About

The unprecedented resolution of Transonic measurements has made Transonic synonymous with gold standard diagnostic and research measurement tools.

From the manufacturer's own website. Source

What Transonic Systems Inc. makes

Transonic Systems Inc. manufactures invasive and noninvasive vascular ultrasound systems for real-time blood flow assessment, including line-powered portable models. The company also produces thermal-dilution cardiac output units for precise hemodynamic monitoring and laser Doppler blood flowmeters for microcirculatory analysis. Additionally, it supplies clinical chemistry analysers for metabolic profiling and surgical anti-adhesion materials designed to prevent tissue adhesion during procedures.

The company’s devices are authorised under FDA 510(k) and UDI regulations in the US and listed in the EU’s eudamed registry, with classifications spanning Class I, Class II, and Class IIa. Its portfolio is regulated according to regional medical device standards, ensuring compliance with invasive, diagnostic, and implantable product requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 34, Dutch Mill Rd., Ithaca, United States
Website: www.transonic.com
LinkedIn: linkedin.com/company/transonic-systems-inc-
Facebook: —
Email: [email protected]
Phone: 607-257-5300
PRRC Contact: Cornelis Drost
EUDAMED SRN: US-MF-000008784
FDA FEI Number: —
DUNS Number: 101317451

Catalogue (713)

Page 14 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	HQG6MB-S	FDA UDI	Class II	Unknown
Transonic	HQD4FMC	FDA UDI	Class II	Unknown
Transonic	H6AUL-5	FDA UDI	Class II	Unknown
Transonic	HT314-FT	FDA UDI	Class II	Unknown
FlowXL Long Pole Mount	FOS1016	EUDAMED	Class I	Active
HD03 Patient-less Measurement Module	PMM	EUDAMED	Class IIa	Active
Tubing Flowsensors	H2XL	EUDAMEDFDA UDI	Class IIa	Active
HD03 Pole mount	PMA1000	EUDAMED	Class I	Active
Tubing Flowsensors	H10XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	HQD6XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	H3XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	H4XL	EUDAMEDFDA UDI	Class IIa	Active
Transonic Hcm 103 System	K134035	FDA 510(k)	Class II	Active
Transonic Costatus Cardiac Output System	K113821	FDA 510(k)	Class II	Active
Aureflo Monitoring System	K112657	FDA 510(k)	Class II	Active
Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models Hvt100, Adt1001, Adt1002	K033424	FDA 510(k)	Class II	Active
Angio Flow Thermodilution Catheter, Model Af-Cath-01; Angioflow Meter, Models Hq100 And Hq101	K010253	FDA 510(k)	Class II	Active
Transonic Hemodialysis Flow Reverser, Model B Flowrev	K002816	FDA 510(k)	Class II	Active
Transonic Flowmeter	K872048	FDA 510(k)	Class II	Active
Transonic Syringe Warmer, Model Syr-1000	K022963	FDA 510(k)	Class II	Active
Transonic Flow-Qc Set Model Adt1010	K021571	FDA 510(k)	Class II	Active
Transonic Elsa System	K134051	FDA 510(k)	Class II	Active
Transonic Costatus Cardiac Output System	K080116	FDA 510(k)	Class II	Active
Advance Laser Flowmeter, Alf 21	K903633	FDA 510(k)	Class II	Active
Transonic Tissue Perfusion Monitor	K140740	FDA 510(k)	Class II	Active
Transonic Hcm 102 System	K140017	FDA 510(k)	Class II	Active
Hd01-Series Transonic Hemodialysis Monitor (r%, Qa, Co, Qb, Qb2)	K960817	FDA 510(k)	Class II	Active
Transonic Hemodialysis Monitor, Cardiac Output, Model Hd01-Co	K980906	FDA 510(k)	Class II	Active
Tubing Flowsensors	HQD9XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	HQD10XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	H11XL	EUDAMEDFDA UDI	Class IIa	Active
FlowXL Short Pole Mount	FOS1015	EUDAMED	Class I	Active
Tubing Flowsensors	HS12XL	EUDAMED	Class IIa	Active
Tubing Flowsensors	H9FX	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	HQD3XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	HS9XL	EUDAMED	Class IIa	Active
Tubing Flowsensors	HQD4XL	EUDAMEDFDA UDI	Class IIa	Active
Integrated mobile cart/trolley with secondary monitor and a printer shelf	AOS1006S	EUDAMED	Class I	Active
FlowXL Tabletop Mount	FOS1014	EUDAMED	Class I	Active
Tubing Flowsensors	H6XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	HS3XL-219	EUDAMED	Class IIa	Active
Tubing Flowsensors	H9XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	H8XL	EUDAMEDFDA UDI	Class IIa	Active
Standard FlowXL Meter with QuickFlow Software	HT520QF	EUDAMED	Class IIa	Active
H4FX Clamp-on Tubing Flowsensors	H4FX	EUDAMEDFDA UDI	Class IIa	Active
HD03 Monitor	HD03	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	HQD12XL	EUDAMEDFDA UDI	Class IIa	Active
Tubing Flowsensors	H12XL	EUDAMEDFDA UDI	Class IIa	Active
Integrated mobile cart/trolley with secondary monitor	AOS1006	EUDAMED	Class I	Active
Tubing Flowsensors	HQD2XL	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Transonic Europe BV NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Transonic Systems Inc. has 11 FDA recall records, all initiated between July 27, 2015, and February 15, 2018, with all records marked as terminated. The reasons cited include concerns about the sterility of a device, stating there is a potential for an increased risk of infection, and software defects in blood flow probes, specifically programming errors causing incorrect readings when connected to flow meters.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 15, 2018	Z-1776-2018	—	terminated	The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Jul 27, 2015	Z-2725-2015	—	terminated	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.
Jul 27, 2015	Z-2720-2015	—	terminated	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.
Jul 27, 2015	Z-2728-2015	—	terminated	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.
Jul 27, 2015	Z-2721-2015	—	terminated	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.
Jul 27, 2015	Z-2723-2015	—	terminated	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.
Jul 27, 2015	Z-2722-2015	—	terminated	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.
Jul 27, 2015	Z-2727-2015	—	terminated	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.
Jul 27, 2015	Z-2726-2015	—	terminated	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.
Jul 27, 2015	Z-2729-2015	—	terminated	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.
Jul 27, 2015	Z-2724-2015	—	terminated	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.