Company ยท US
Transonic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2015. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2015 | K140740 | TRANSONIC TISSUE PERFUSION MONITOR Transonic Systems, Inc. | DPW |
| Jan 29, 2015 | K134051 | TRANSONIC ELSA SYSTEM Transonic Systems, Inc. | DXG |
| Sep 17, 2014 | K134035 | TRANSONIC HCM 103 SYSTEM Transonic Systems, Inc. | DXG |
| Sep 16, 2014 | K140017 | TRANSONIC HCM 102 SYSTEM Transonic Systems, Inc. | DXG |
| Sep 7, 2012 | K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc. | DXG |
| Dec 21, 2011 | K112657 | AUREFLO MONITORING SYSTEM Transonic Systems, Inc. | DPW |
| Sep 8, 2008 | K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc. | DXG |
| Dec 11, 2003 | K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 Transonic Systems, Inc. | DPW |
| Dec 4, 2002 | K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 Transonic Systems, Inc. | MQS |
| Aug 12, 2002 | K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 Transonic Systems, Inc. | MQS |
| Mar 19, 2002 | K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 Transonic Systems, Inc. | DYG |
| Nov 22, 2000 | K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV Transonic Systems, Inc. | KOC |
| Oct 6, 1998 | K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO Transonic Systems, Inc. | MQS |
| Feb 11, 1997 | K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) Transonic Systems, Inc. | MQS |
| Oct 9, 1990 | K903633 | ADVANCE LASER FLOWMETER, ALF 21 Transonic Systems, Inc. | DPW |
| Jun 21, 1988 | K872048 | TRANSONIC FLOWMETER Transonic Systems, Inc. | DPW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Transonic Systems Inc 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 us Terminated |
PEH | K021571 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 3 mm, Catalog Number HQC3MP --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 2 mm, Catalog Number HQC2MP --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC --
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Sep 3, 2015 | Transonic Systems Inc Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC
Product Usage:
to measure flow intra-operatively. Terminated |
DPW | K872048 |
| Mar 18, 2015 | Transonic Systems Inc 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 recirculat Terminated |
MQS | K960817 |
| Apr 18, 2013 | Transonic Systems Inc 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 Terminated |
DXG | K080116 |