510(k) · Cleared
Recalled · Class II · 2015Transonic Flowmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transonic Systems, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Jun 21, 1988 after a 390-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 18 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it. It has been recalled 10 times.
- Decided
- Jun 21, 1988
- Review
- 390 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 10
- Predicates
- 0
17 later devices descend from it, 4 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- This deviceK872048 Transonic FlowmeterTransonic Systems, Inc. · 1988
- Descendant · cites it directly · 10 of its ownK072131 M3 MonitorSpectrum Medical, Ltd. · 2007
- Descendant · 2 generations on · 5 of its ownK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · cites it directly · 4 of its ownK992305 Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004Medi-Stim A/S · 1999
- Descendant · 4 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K072131M3 MonitorSpectrum Medical, Ltd. · 2007 · cites it directly10descendants
- K091908M3 MonitorSpectrum Medical, Ltd. · 2009 · 2 generations on5descendants
- K110957M4 MonitorSpectrum Medical, Llp · 2011 · 3 generations on4descendants
- K992305Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004Medi-Stim A/S · 1999 · cites it directly4descendants
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872048 | Transonic Flowmeter | Transonic Systems, Inc. | 1988 | — |
| +1 | K072131 | M3 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| +2 | K091908 | M3 Monitor | Spectrum Medical, Ltd. | 2009 | 1 |
| +3 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +1 | K992305 | Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004 | Medi-Stim A/S | 1999 | — |
| +4 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 174 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2015 | Class II | Z-2727-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2724-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2720-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2723-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2725-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2729-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2722-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2726-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2728-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
| Jul 27, 2015 | Class II | Z-2721-2015 | Software Manufacturing/Software Deployment | 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 Used Probe or Irrelevant Use Number. |
The 5 latest of 10 recalls; the web page lists all.
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.
What does this lineage say?
- Of its descendants, K072131 (Spectrum Medical, Ltd., 2007) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K872048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K872048: Transonic Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872048
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026