510(k) · Cleared

Cleared

Aureflo Monitoring System

K112657510(k) TraditionalCleared Dec 21, 201199-day reviewClass II21 CFR 870.2100

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

Transonic Systems, Inc. · DPW Flowmeter, Blood, Cardiovascular

Cleared on Dec 21, 2011 as substantially equivalent to K040228 (Medi-Stim A/S, 2004) after a 99-day review. Its family tree reaches back 3 generations to 1988.

Decided: Dec 21, 2011
Review: 99 days
Class: Class II
Product code: DPW
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K872048 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK872048 Transonic FlowmeterTransonic Systems, Inc. · 1988 · Recalled
2 generations backK992305 Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004Medi-Stim A/S · 1999
1 generation backK040228 Medi-Stim Veriq System, Model VQ1001 - VQ4122Medi-Stim A/S · 2004 · Recalled
This deviceK112657 Aureflo Monitoring SystemTransonic Systems, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K872048	Transonic Flowmeter	Transonic Systems, Inc.	1988	10
−2	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
0 (this device)	K112657	Aureflo Monitoring System	Transonic Systems, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2002	1	0

FIG. 1 — Lineage of K112657, 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 DPW? 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

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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
*	K040228	Medi-Stim Veriq System, Model VQ1001 - VQ4122 Summary page 1 …Common/Usual Name - Blood Flowmeter Proprietary Name - Aure Flo Monitoring System Predicate Device: K040228 Medi-Stim VeriQ System Device Description In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transo…	Medi-Stim A/S	2004	1

Also cleared against K040228: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
2 of the 5 ancestors have a recall of any class.
1 other device also cites its predicate K040228.

How does its category compare?

All DPW devices

DPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DPW

3in 2025

2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPW

119in 2025

2007high 275 (2015) · low 89 (2011)2026

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

Recalls per year · DPW

1in 2025

2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPW

6in 2025

2007high 12 (2015) · low 0 (2007)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	—

What is it indicated for?

Read the full statement (118 words)

The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric patients for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts: where surgery is medically indicated; intraoperatively, rather than in chronic implant: at intraoperative sites which admit and retain ultrasonic couplant: with minimal vessel manipulation or constriction (to avoid vessel spasm): where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112657: Aureflo Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112657

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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