510(k) · Cleared

Recalled · 2004

TCD 100M, PWD13 Transducer

K002533510(k) TraditionalCleared Aug 30, 200014-day reviewClass II21 CFR 892.1550Recalls 1

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

Spencer Technologies · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 30, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it. It has been recalled once.

Decided: Aug 30, 2000
Review: 14 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 0

32 later devices descend from it, 7 citing it directly.

This deviceK002533 TCD 100M, PWD13 TransducerSpencer Technologies · 2000
Descendant · cites it directly · 19 of its ownK041826 Ekos Ultrasound Infusion SystemEkos Corp. · 2005
Descendant · 2 generations on · 18 of its ownK051225 Ekos Micro-Infusion SystemEkos Corp. · 2005
Descendant · 3 generations on · 16 of its ownK053437 Ekos Micro-Infusion SystemEkos Corp. · 2006
Descendant · 3 generations on · 16 of its ownK053432 Ekos Micro-Infusion SystemEkos Corp. · 2005
Descendant · 4 generations on · 14 of its ownK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005high 4 (2005) · low 0 (2010)2026

Most influential descendants

Showing 5 of 32 · See all

K041826Ekos Ultrasound Infusion SystemEkos Corp. · 2005 · cites it directly19descendants
K051225Ekos Micro-Infusion SystemEkos Corp. · 2005 · 2 generations on18descendants
K053437Ekos Micro-Infusion SystemEkos Corp. · 2006 · 3 generations on16descendants
K053432Ekos Micro-Infusion SystemEkos Corp. · 2005 · 3 generations on16descendants
K062508Neurowave Micro-Infusion SystemEkos Corp. · 2006 · 4 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002533	TCD 100M, PWD13 Transducer	Spencer Technologies	2000	—
+1	K041826	Ekos Ultrasound Infusion System	Ekos Corp.	2005	—
+2	K051225	Ekos Micro-Infusion System	Ekos Corp.	2005	—
+3	K053437	Ekos Micro-Infusion System	Ekos Corp.	2006	—
+3	K053432	Ekos Micro-Infusion System	Ekos Corp.	2005	—
+4	K062508	Neurowave Micro-Infusion System	Ekos Corp.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	4	0
2007	1	0
2008	3	0
2009	1	0
2011	2	0
2012	1	0
2014	1	0
2016	1	0
2017	1	0
2018	1	0
2019	4	0
2020	2	0
2021	2	0
2022	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K002533, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in IYN? 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 IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K041826	Ekos Ultrasound Infusion System	Ekos Corp.	2005	19
K051085	Doppler-Box	Compumedics Germany Gmgh	2005	5
K060421	Sonara; Sonara/Tek	Viasys Healthcare, Inc.	2006	3
K160442	Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers	Neural Analytics, Inc.	2016	2
K123565	Presto 1000 System	Physiosonics, Inc.	2012	0
K110752	Highland Instruments Ces and Tus Instrument Holder	Highland Instruments	2011	0
K092204	PMD Viewer	Spencer Technologies	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 19, 2004	Not classified	Z-0788-04	Other	Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K041826 (Ekos Corp., 2005) has gone furthest, with 19 descendants of its own.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

https://510kreport.com/device/K002533 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002533: TCD 100M, PWD13 Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002533

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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