510(k) · Cleared

Cleared

Devmed Stepping and Stabilizing System

K972152510(k) TraditionalCleared Aug 15, 199767-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

Devmed Corp. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Aug 15, 1997 as substantially equivalent to K864807 (Teknar, Inc., 1987) and 4 other predicates after a 67-day review. Its family tree reaches back 1 generation to 1980. 4 later devices descend from it.

Decided: Aug 15, 1997
Review: 67 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K802032 (1980). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK802032 Mini Mick ApplicatorMick Radio-Nuclear Instruments, Inc. · 1980
This deviceK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
Descendant · cites it directly · 3 of its ownK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
Descendant · 2 generations on · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
Descendant · cites it directly · 0 of its ownK030518 Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003
Descendant · cites it directly · 0 of its ownK024183 Alton PT StepperAlton Design, LLC · 2003

Most influential descendants

Showing 4 of 4 · See all

K011581Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001 · cites it directly3descendants
K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · 2 generations on0descendants
K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003 · cites it directly0descendants
K024183Alton PT StepperAlton Design, LLC · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K802032	Mini Mick Applicator	Mick Radio-Nuclear Instruments, Inc.	1980	—
0 (this device)	K972152	Devmed Stepping and Stabilizing System	Devmed Corp.	1997	—
+1	K011581	Ameritek Brachytherapy Template	Amertek Medical, Inc.	2001	—
+2	K031273	Ameritek Sure-Point HDR Needle Template	Amertek Medical, Inc.	2003	—
+1	K030518	Ameritek Sure-Point Tracker System	Amertek Medical, Inc.	2003	—
+1	K024183	Alton PT Stepper	Alton Design, LLC	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	2	0
1992	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	3	0

FIG. 1 — Lineage of K972152, 1980–2003Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K864807	Teknar Proscan (TM) Summary page 1 …intended use, as the equivalent devices the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above. 2. The technological characteristics for this product are the same as those for the pred…	Teknar, Inc.	1987	—
*	K871413	Civco Stepper Summary page 1 …d™ Stepping and Stabilizing System is substantiaily equivalent to the classified device and those cleared for marketing by the 510(k) process under K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K-963302 (Tayman Medical). The "510(k) "Substantial Equivalence" Decision-Making Process…	CIVCO Medical Instruments Co., Inc.	1987	—
*	K913293	Quick Seeder Summary page 1 …w: 1. These products have the same intended use, as the equivalent devices the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above. 2. The technological characteristics for this produc…	Mick Radio-Nuclear Instruments, Inc.	1992	—
*	K963302	Tayman Medical, Inc. Stepping & Stabilizing System Summary page 1 …ly equivalent to the classified device and those cleared for marketing by the 510(k) process under K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K-963302 (Tayman Medical). The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 wa…	Tayman Medical, Inc.	1997	1
*	K802032	Mini Mick Applicator Summary page 1 …scribed below: 1. These products have the same intended use, as the equivalent devices the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above. 2. The technological characteristics for…	Mick Radio-Nuclear Instruments, Inc.	1980	—

Also cleared against K864807: 4 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K011581	Ameritek Brachytherapy Template	Amertek Medical, Inc.	2001	3
K030518	Ameritek Sure-Point Tracker System	Amertek Medical, Inc.	2003	0
K024183	Alton PT Stepper	Alton Design, LLC	2003	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?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K011581 (Amertek Medical, Inc., 2001) has gone furthest, with 3 descendants of its own.
4 other devices also cite its predicate K864807.

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?

The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed.implantation.in brachytherapy treatments. A specific application. is the treatment-of prostate tancer.

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/K972152 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972152: Devmed Stepping and Stabilizing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972152

Report an extraction error

Are you the manufacturer?

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