510(k) Report

FDA applicant

Transonic Systems, Inc.

Ithaca, NY16 decisions1988–201513 recalls

FDA records 16 decisions for Transonic Systems, Inc. (Ithaca, NY) from 1988 to 2015: 16 510(k) clearances. Most are in product codes DXG (Computer, Diagnostic, Pre-Programmed…) and DPW (Flowmeter, Blood, Cardiovascular). Its devices cite 17 predicates, 10 of them its own earlier devices. 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Transonic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2008: 12011: 12012: 12014: 22015: 2
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2013: 12015: 112018: 1
2007high 11 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Transonic Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Transonic Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function5decisions
  • DPWFlowmeter, Blood, Cardiovascular5decisions
  • MQSSystem, Hemodialysis, Access Recirculation Monitoring4decisions
  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • DYGCatheter, Flow Directed1decision

Whose devices does it build on?

Its devices cite 17 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K960817HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 19974cite it
  • K872048Transonic FlowmeterTransonic Systems, Inc. · 19884cite it
  • K980906Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 19984cite it
  • K903633Advance Laser Flowmeter, Alf 21Transonic Systems, Inc. · 19902cite it
  • K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 20121cites it
  • K002816Transonic Hemodialysis Flow Reverser, Model B FlowrevTransonic Systems, Inc. · 20001cites it

What has FDA decided for it lately?

  • K140740Transonic Tissue Perfusion MonitorTransonic Systems, Inc. · 2015
  • K134051Transonic Elsa SystemTransonic Systems, Inc. · 2015
  • K134035Transonic HCM 103 SystemTransonic Systems, Inc. · 2014
  • K140017Transonic HCM 102 SystemTransonic Systems, Inc. · 2014
  • K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012
  • K112657Aureflo Monitoring SystemTransonic Systems, Inc. · 2011
  • K080116Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 20081 recall
  • K033424Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models HVT100, ADT1001, ADT1002Transonic Systems, Inc. · 2003

All 16 as Transonic Systems, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K021571Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The…Feb 15, 2018Class II
  • K872048Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow…Jul 27, 2015Class II
  • K872048Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow…Jul 27, 2015Class II
  • K872048Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow…Jul 27, 2015Class II
  • K872048Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow…Jul 27, 2015Class II
  • K872048Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow…Jul 27, 2015Class II