Transonic Systems, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Transonic Systems, Inc.” (first 1988, latest 2015), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 246 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 255 |
| 2013 | 0 | — |
| 2014 | 2 | 258 |
| 2015 | 2 | 440 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 5 | 5 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 5 | 5 |
| MQS | System, Hemodialysis, Access Recirculation Monitoring | 4 | 4 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
Most recent Transonic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | DPW | 2015-07-23 | 485 |
| K134051 | TRANSONIC ELSA SYSTEM | DXG | 2015-01-29 | 394 |
| K134035 | TRANSONIC HCM 103 SYSTEM | DXG | 2014-09-17 | 260 |
| K140017 | TRANSONIC HCM 102 SYSTEM | DXG | 2014-09-16 | 257 |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | DXG | 2012-09-07 | 255 |
| K112657 | AUREFLO MONITORING SYSTEM | DPW | 2011-12-21 | 99 |
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | DXG | 2008-09-08 | 236 |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 | DPW | 2003-12-11 | 49 |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | MQS | 2002-12-04 | 89 |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | MQS | 2002-08-12 | 90 |
6 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-02-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Transonic Systems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01610622: Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique (Completed, started 2012-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Transonic Systems, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Transonic Systems, Inc.” (first 1988, latest 2015), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Transonic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transonic Systems, Inc. is 246 days.
Which FDA product codes appear under Transonic Systems, Inc.?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 5); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 5); MQS (System, Hemodialysis, Access Recirculation Monitoring, 4).
Next steps
- See all 16 Transonic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPW, Transonic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.