# K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Feb 11, 1997 after 349 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 4 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BUN on Boehringer Mannheim Hitachi 911 Analyzer: named in the summary without a submission number
- (no number) Philips P700 ultrasound system with CVI-Q option: named in the summary without a submission number
- (no number) Fresenius 2008 Dialysis System (pump readout only): named in the summary without a submission number
- (no number) Transonic T101D/T201D with 8C clamp-on flow probe: named in the summary without a submission number

## Most influential descendants
- K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO (1998), 10 descendants of its own
- K982412: Modification of Crit-Line Monitor Iii (CLM Iii) (1998), 6 descendants of its own
- K030456: Vasc-Alert (2003), 5 descendants of its own
- K060008: Aquadex Flexflow System (2006), 4 descendants of its own
- K042566: Vasc-Alert (2004), 4 descendants of its own

## Recalls of this device
- Feb 17, 2015 · Class II · Z-1295-2015: 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 n

## Indications for use
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.

Source page: https://510kreport.com/device/K960817
Methodology: https://510kreport.com/methodology