510(k) · Cleared
Recalled · Class II · 2015HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transonic Systems, Inc. · MQS System, Hemodialysis, Access Recirculation Monitoring
Cleared on Feb 11, 1997 after a 349-day review. The FDA summary names its predicate without a number. 1 of the 19 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it. It has been recalled once.
- Decided
- Feb 11, 1997
- Review
- 349 days
- Class
- Class II
- Product code
- MQS
- Recalls
- 1
- Predicates
- 0
18 later devices descend from it, 4 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- This deviceK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK982412 Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998
- Descendant · cites it directly · 5 of its ownK030456 Vasc-AlertVasc-Alert, LLC · 2003
- Descendant · 2 generations on · 4 of its ownK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK042566 Vasc-AlertVasc-Alert, Inc. · 2004
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.06 generations on · 2020
Most influential descendants
Showing 5 of 18 · See all- K980906Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998 · cites it directly10descendants
- K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998 · cites it directly6descendants
- K030456Vasc-AlertVasc-Alert, LLC · 2003 · cites it directly5descendants
- K060008Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 2 generations on4descendants
- K042566Vasc-AlertVasc-Alert, Inc. · 2004 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | — |
| +1 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| +1 | K982412 | Modification of Crit-Line Monitor Iii (CLM Iii) | In-Line Diagnostics Corp. | 1998 | — |
| +1 | K030456 | Vasc-Alert | Vasc-Alert, LLC | 2003 | — |
| +2 | K060008 | Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +2 | K042566 | Vasc-Alert | Vasc-Alert, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 2023 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | — | BUN on Boehringer Mannheim Hitachi 911 Analyzer Named without a submission number | |
| * | — | Philips P700 ultrasound system with CVI-Q option Named without a submission number | |
| * | — | Fresenius 2008 Dialysis System (pump readout only) Named without a submission number | |
| * | — | Transonic T101D/T201D with 8C clamp-on flow probe Named without a submission number |
What descends from it? (18)
See all 184 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2015 | Class II | Z-1295-2015 | Process control | Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K980906 (Transonic Systems, Inc., 1998) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MQS devicesMQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQS
1in 2023
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 68 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HDO1-series monitors are intended for use by trained medical personnel on patients receiving hemodialysis treatment, for the routine monitoring of the following patient and blood handling diagnostic parameters: Access recirculation: a check on proper dialysis needle placement and dialysis pump setting in relation to flow in the access device. Access recirculation would prevent the patient of receiving its full hemodialysis prescription. Access…
Read the full statement (168 words)
The HDO1-series monitors are intended for use by trained medical personnel on patients receiving hemodialysis treatment, for the routine monitoring of the following patient and blood handling diagnostic parameters:
Access recirculation: a check on proper dialysis needle placement and dialysis pump setting in relation to flow in the access device. Access recirculation would prevent the patient of receiving its full hemodialysis prescription. Access recirculation that cannot be mitigated by altering needle placement should be referred to the attending physician, for a change in the patient hemodialysis prescription and as a possible indication of deteriorating flow in the access device.
Access flow: allows the routine monitoring of patency of the access device. A substantial decrease in flow passing through the shunt or fistula from the initial level may indicate deterioration of the access, and should be referred to the attending physician for further diagnostic assessment and treatment.
[unreadable]: a check on the hemodialysis pump setting, to confirm that the patient receives the hemodialysis treatment prescribed by the attending physician.
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/K960817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960817
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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