510(k) · Cleared

Cleared

Cook-Swartz Doppler Flow Probe

K171272510(k) TraditionalCleared Jul 17, 2018442-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

Cook Incorporated · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Jul 17, 2018 as substantially equivalent to K022649 (Cook Vascular, Inc., 2002) after a 442-day review. Its family tree reaches back 2 generations to 1998.

Decided: Jul 17, 2018
Review: 442 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K964001 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK964001 Swartz Doppler Flow Probe and Monitor SystemMed Institute, Inc. · 1998
1 generation backK022649 Cook-Swartz Doppler Flow ProbeCook Vascular, Inc. · 2002
This deviceK171272 Cook-Swartz Doppler Flow ProbeCook Incorporated · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K964001	Swartz Doppler Flow Probe and Monitor System	Med Institute, Inc.	1998	—
−1	K022649	Cook-Swartz Doppler Flow Probe	Cook Vascular, Inc.	2002	—
0 (this device)	K171272	Cook-Swartz Doppler Flow Probe	Cook Incorporated	2018	—

FIG. 1 — Lineage of K171272, 1998–2018Source: 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
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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
*	K022649	Cook-Swartz Doppler Flow Probe Summary page 5 …Device: The Cook-Swartz Doppler Flow Probe, is substantially equivalent to the predicate device, the previously-submitted Cook-Swartz Doppler Flow Probe as described in K022649. Device Description The Cook-Swartz Doppler Flow Probe contains a piezoelectric crystal transducer assembly at its distal end.…	Cook Vascular, Inc.	2002	—

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 20 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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?

The Cook-Swartz Doppler Flow Probe is for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.

The Cook-Swartz Doppler Flow Probe is intended for use with the Swartz Doppler Monitoring System for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171272 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171272: Cook-Swartz Doppler Flow Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171272

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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