Transonic Systems Inc
FDA Regulatory Profile
Transonic Systems Inc appears in FDA public data with 13 recalls, 16 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1776-2018, Class II) was initiated on February 15, 2018. Its most recent 510(k) clearance was granted on July 23, 2015.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 16
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1776-2018 | Class II | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is i | February 15, 2018 |
| Z-2727-2015 | Class II | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operat | July 27, 2015 |
| Z-2724-2015 | Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-opera | July 27, 2015 |
| Z-2723-2015 | Class II | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operat | July 27, 2015 |
| Z-2720-2015 | Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operati | July 27, 2015 |
| Z-2725-2015 | Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operati | July 27, 2015 |
| Z-2728-2015 | Class II | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operativ | July 27, 2015 |
| Z-2721-2015 | Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-opera | July 27, 2015 |
| Z-2722-2015 | Class II | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-oper | July 27, 2015 |
| Z-2729-2015 | Class II | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-oper | July 27, 2015 |
| Z-2726-2015 | Class II | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operat | July 27, 2015 |
| Z-1295-2015 | Class II | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is inte | February 17, 2015 |
| Z-1147-2013 | Class II | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with | March 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | July 23, 2015 |
| K134051 | TRANSONIC ELSA SYSTEM | January 29, 2015 |
| K134035 | TRANSONIC HCM 103 SYSTEM | September 17, 2014 |
| K140017 | TRANSONIC HCM 102 SYSTEM | September 16, 2014 |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | September 7, 2012 |
| K112657 | AUREFLO MONITORING SYSTEM | December 21, 2011 |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | September 8, 2008 |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001 | December 11, 2003 |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | December 4, 2002 |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | August 12, 2002 |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | March 19, 2002 |
| K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV | November 22, 2000 |
| K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | October 6, 1998 |
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | February 11, 1997 |
| K903633 | ADVANCE LASER FLOWMETER, ALF 21 | October 9, 1990 |
| K872048 | TRANSONIC FLOWMETER | June 21, 1988 |