510(k) · Cleared

Cleared

Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004

K992305510(k) TraditionalCleared Sep 8, 199962-day reviewClass II21 CFR 892.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medi-Stim A/S · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Sep 8, 1999 as substantially equivalent to K872048 (Transonic Systems, Inc., 1988) after a 62-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.

Decided: Sep 8, 1999
Review: 62 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K872048 (1988). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK872048 Transonic FlowmeterTransonic Systems, Inc. · 1988 · Recalled
This deviceK992305 Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004Medi-Stim A/S · 1999
Descendant · cites it directly · 2 of its ownK040228 Medi-Stim Veriq System, Model VQ1001 - VQ4122Medi-Stim A/S · 2004 · Recalled
Descendant · 2 generations on · 0 of its ownK112657 Aureflo Monitoring SystemTransonic Systems, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK102595 Medistim Veriqc SystemMedi-Stim Asa · 2010 · Recalled
Descendant · cites it directly · 0 of its ownK050088 Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel…Neoprobe Corp. · 2005

Most influential descendants

Showing 4 of 4 · See all

K040228Medi-Stim Veriq System, Model VQ1001 - VQ4122Medi-Stim A/S · 2004 · cites it directly2descendants
K112657Aureflo Monitoring SystemTransonic Systems, Inc. · 2011 · 2 generations on0descendants
K102595Medistim Veriqc SystemMedi-Stim Asa · 2010 · 2 generations on0descendants
K050088Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerNeoprobe Corp. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872048	Transonic Flowmeter	Transonic Systems, Inc.	1988	10
0 (this device)	K992305	Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004	Medi-Stim A/S	1999	—
+1	K040228	Medi-Stim Veriq System, Model VQ1001 - VQ4122	Medi-Stim A/S	2004	1
+2	K112657	Aureflo Monitoring System	Transonic Systems, Inc.	2011	—
+2	K102595	Medistim Veriqc System	Medi-Stim Asa	2010	1
+1	K050088	Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer	Neoprobe Corp.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K992305, 1988–2011Source: 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 ITX? 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 ITX device

#1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K872048	Transonic Flowmeter Summary page 1 …& Marketing Medi-Stim Butterfly Flowmeter Cardiovascular Blood Flowmeter Class II Transonic Flowmeter Transonic Systems. Inc. 34 Dutch Mill Road Ithaca, NY 14850 K872048 The Medi-Stim Butterfly Flowmeter estimates blood volume flow by measuring the transit time difference between an ultrasonic sig…	Transonic Systems, Inc.	1988	10

Also cleared against K872048: 3 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K040228	Medi-Stim Veriq System, Model VQ1001 - VQ4122	Medi-Stim A/S	2004	2
K050088	Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer	Neoprobe Corp.	2005	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, K040228 (Medi-Stim A/S, 2004) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K872048.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007high 213 (2023) · low 16 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ITX

2in 2025

2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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	10	26	0	16
2008	12	73	4	39
2009	17	28	4	23
2010	10	42	4	30
2011	10	16	1	34
2012	7	25	1	29
2013	3	105	0	38
2014	4	41	1	43
2015	1	—	5	183
2016	4	151	0	269
2017	6	110	1	412
2018	2	—	15	130
2019	1	—	0	119
2020	3	120	3	116
2021	3	139	10 (10)	146
2022	2	—	6	87
2023	6	213	1	138
2024	3	81	1	988
2025	4	126	2	571
2026	6	158	0	—

What is it indicated for?

It is intended for accurate transit time blood volume flow measurements during cardiovascular, vascular and transplantation surgery.

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/K992305 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992305: Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992305

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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