# K872048: Transonic Flowmeter

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Jun 21, 1988 after 390 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072131: M3 Monitor (2007), 10 descendants of its own
- K091908: M3 Monitor (2009), 5 descendants of its own
- K110957: M4 Monitor (2011), 4 descendants of its own
- K992305: Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004 (1999), 4 descendants of its own
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), 3 descendants of its own

## Recalls of this device
- Jul 27, 2015 · Class II · Z-2727-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2724-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2720-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2723-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2725-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2729-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2722-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2726-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2728-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us
- Jul 27, 2015 · Class II · Z-2721-2015: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Us

Source page: https://510kreport.com/device/K872048
Methodology: https://510kreport.com/methodology