510(k) Report

510(k) · Cleared

Cleared

Transonic Syringe Warmer, Model Syr-1000

K022963510(k) TraditionalCleared Dec 4, 200289-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Transonic Systems, Inc. · MQS System, Hemodialysis, Access Recirculation Monitoring

Cleared on Dec 4, 2002 as substantially equivalent to K980906 (Transonic Systems, Inc., 1998) after an 89-day review. Its family tree reaches back 2 generations to 1997.

Decided
Dec 4, 2002
Review
89 days
Class
Class II
Product code
MQS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K960817 (1997). No later device cites it as a predicate yet.

K960817 · HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) · Transonic Systems, Inc. · 1997 · recalledK980906 · Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO · Transonic Systems, Inc. · 199819961998200020022004
K980906 · Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO · Transonic Systems, Inc. · 1998K960817 · HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) · Transonic Systems, Inc. · 1997 · recalled0
  1. Root · 2 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
  2. 1 generation backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
  3. This deviceK022963 Transonic Syringe Warmer, Model Syr-1000Transonic Systems, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960817HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc.19971
−1K980906Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc.1998—
0 (this device)K022963Transonic Syringe Warmer, Model Syr-1000Transonic Systems, Inc.2002—
FIG. 1 — Lineage of K022963, 1997–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQS device

  1. #1 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K980906Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO
Summary page 1
…mber Name Applicant I K980906 HDOl-CO Hemodialysis Monitor Transonic Systems Inc.…
Transonic Systems, Inc.1998—
*—Vista Dental Syringe Warmer
Named without a submission number
—

Also cleared against K980906: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K980906.

How does its category compare?

All MQS devices

MQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQS

1in 2023

2013: 12019: 12023: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQS

Too few MQS 510(k)s in any year since 2007 to give a median.

Recalls per year · MQS

No recall names MQS since 2007.

Adverse event reports per year · MQS

5in 2013

2007: 682008: 62009: 212010: 102011: 12012: 52013: 5
2007high 68 (2007) · low 0 (2014)2025

MAUDE reports naming product code MQS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—068
20080—06
20090—021
20100—010
20110—01
20120—05
20131—05
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD0l (HDO1p'usand HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HDOl-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HDO1p'usand HD02 systems. The HDO1-CO Hemodialysis Monitor for Cardiac Output (HDOlp'usand HD02 systems) requires the user to make a 30cc…

Read the full statement (102 words)

The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD0l (HDO1p'usand HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HDOl-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HDO1p'usand HD02 systems. The HDO1-CO Hemodialysis Monitor for Cardiac Output (HDOlp'usand HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.

Indications for use as stated in the FDA summary.

Also cleared against K980906

3 other devices cite the same predicate.

  • K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012
  • K080116Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 20081 recall
  • K030456Vasc-AlertVasc-Alert, LLC · 2003

More from Transonic Systems, Inc.

16 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in MQS

The MQS category page

  • K232283PhySoftAMS®Physician Software Systems, LLC · 2023
  • K180410Dosis SAMDosis, Inc. · 2019
  • K130579Physoft AmsPhysicians Software Systems, LLC · 2013
  • K042566Vasc-AlertVasc-Alert, Inc. · 2004
  • K021571Transonic Flow-QC Set Model ADT1010Transonic Systems, Inc. · 20021 recall

https://510kreport.com/device/K022963 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022963: Transonic Syringe Warmer, Model Syr-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022963

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026