510(k) · Cleared

Cleared

Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO

K980906510(k) TraditionalCleared Oct 6, 1998210-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 Oct 6, 1998 as substantially equivalent to K960817 (Transonic Systems, Inc., 1997) after a 210-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it.

Decided: Oct 6, 1998
Review: 210 days
Class: Class II
Product code: MQS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960817 (1997). 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
This deviceK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
Descendant · cites it directly · 5 of its ownK030456 Vasc-AlertVasc-Alert, LLC · 2003
Descendant · 2 generations on · 4 of its ownK042566 Vasc-AlertVasc-Alert, Inc. · 2004
Descendant · 3 generations on · 3 of its ownK093834 Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010
Descendant · 4 generations on · 2 of its ownK130579 Physoft AmsPhysicians Software Systems, LLC · 2013
Descendant · cites it directly · 2 of its ownK080116 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002high 1 (2002) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K030456Vasc-AlertVasc-Alert, LLC · 2003 · cites it directly5descendants
K042566Vasc-AlertVasc-Alert, Inc. · 2004 · 2 generations on4descendants
K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010 · 3 generations on3descendants
K130579Physoft AmsPhysicians Software Systems, LLC · 2013 · 4 generations on2descendants
K080116Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960817	HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)	Transonic Systems, Inc.	1997	1
0 (this device)	K980906	Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO	Transonic Systems, Inc.	1998	—
+1	K030456	Vasc-Alert	Vasc-Alert, LLC	2003	—
+2	K042566	Vasc-Alert	Vasc-Alert, Inc.	2004	—
+3	K093834	Crit-Line Anemia Management Software	Hema Metrics, LLC	2010	—
+4	K130579	Physoft Ams	Physicians Software Systems, LLC	2013	—
+1	K080116	Transonic Costatus Cardiac Output System	Transonic Systems, Inc.	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2008	1	0
2010	1	0
2012	1	0
2013	1	0
2015	1	0
2019	1	0
2023	1	0

FIG. 1 — Lineage of K980906, 1997–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K960817	HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) Our OCR of the scanned summary read “K960817” beside “510(k)”; FDA’s K960817 is the only number that fits it and carries the summary’s name for the device. Summary page 5 …on flow/dilution sensors are 25 to 40 dB below FDA CDRH maximum pre-amendment levels for "Fetal Doppler and Other" applications, and have passed FDA review under 510(k) #K960817 All procedures required to execute these measurements (saline injection, change in blood line connections) are standard clinica…	Transonic Systems, Inc.	1997	1

Also cleared against K960817: 3 other devices →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030456	Vasc-Alert	Vasc-Alert, LLC	2003	5
K080116	Transonic Costatus Cardiac Output System	Transonic Systems, Inc.	2008	2
K113821	Transonic Costatus Cardiac Output System	Transonic Systems, Inc.	2012	1
K022963	Transonic Syringe Warmer, Model Syr-1000	Transonic Systems, Inc.	2002	0

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?

Its one ancestor has a recall.
Of its descendants, K030456 (Vasc-Alert, LLC, 2003) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K960817.

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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	68
2008	0	—	6
2009	0	—	21
2010	0	—	10
2011	0	—	1
2012	0	—	5
2013	1	—	5
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The HDO1-CO monitor is intended for use by trained medical personnel, for assessment of a patient’s hemodynamic condition through estimation of cardiac output while undergoing hemodialysis treatment in a non-critical care setting.

For use only by or on the order of a physician licensed by law to use or order the use of this device.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980906 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980906

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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