510(k) · Cleared

Cleared

Ameritek Sure-Point Tracker System

K030518510(k) TraditionalCleared May 20, 200390-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

Amertek Medical, Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on May 20, 2003 as substantially equivalent to K972152 (Devmed Corp., 1997) and 10 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1980.

Decided: May 20, 2003
Review: 90 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 12

Its longest line of descent runs back 3 generations to K802032 (1980). 12 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK802032 Mini Mick ApplicatorMick Radio-Nuclear Instruments, Inc. · 1980
2 generations backK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
1 generation backK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
This deviceK030518 Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K802032	Mini Mick Applicator	Mick Radio-Nuclear Instruments, Inc.	1980	—
−2	K972152	Devmed Stepping and Stabilizing System	Devmed Corp.	1997	—
−1	K011581	Ameritek Brachytherapy Template	Amertek Medical, Inc.	2001	—
0 (this device)	K030518	Ameritek Sure-Point Tracker System	Amertek Medical, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	2	0
1988	1	0
1992	1	0
1997	1	0
1998	1	0
1999	1	0
2000	2	0

FIG. 1 — Lineage of K030518, 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
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What was it cleared against? (12)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K972152	Devmed Stepping and Stabilizing System Summary page 1 …described below: 1. These products have the same intended uses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process under K972152 (Devmed, Inc.), KO11581 (Amertek Inc.), K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed…	Devmed Corp.	1997	—
*	K011581	Ameritek Brachytherapy Template Summary page 1 …Class II,CFR 892.1570 VII. Substantial Equivalence: Amertekm is substantially equivalent (and nearly identical to) its predecessor devices cleared under K-972152 and K-011581. It is also equivalent to devices cleared for marketing by the 51O(k) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar…	Amertek Medical, Inc.	2001	—
*	K000960	Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900 Summary page 1 …nd nearly identical to) its predecessor devices cleared under K-972152 and K-011581. It is also equivalent to devices cleared for marketing by the 51O(k) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Ga…	Barzell-Whitmore Maroon Bells, Inc.	2000	—
*	K864807	Teknar Proscan (TM) Summary page 1 …ose cleared for marketing as equivalent to it by the 510(k) process under K972152 (Devmed, Inc.), KO11581 (Amertek Inc.), 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 …cleared under K-972152 and K-011581. It is also equivalent to devices cleared for marketing by the 51O(k) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270…	CIVCO Medical Instruments Co., Inc.	1987	—
*	K913293	Quick Seeder Summary page 1 …ses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process under K972152 (Devmed, Inc.), KO11581 (Amertek Inc.), 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	—
Kept off the family tree	K961303	Life Imaging Systems Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …o equivalent to devices cleared for marketing by the 51O(k) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270 (Nucletron Corp.) and K-963302 (Tayman Medical…
*	K991517	Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Summary page 1 …for marketing by the 51O(k) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270 (Nucletron Corp.) and K-963302 (Tayman Medical). The "51O(k) "Substantial Equ…	Galil Medical, Ltd.	1999	—
*	K881605	Biopsy Guide Summary page 1 …) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270 (Nucletron Corp.) and K-963302 (Tayman Medical). The "51O(k) "Substantial Equivalence" Decision-Making…	Teknar, Inc.	1988	—
*	K003270	Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 Summary page 1 …(Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270 (Nucletron Corp.) and K-963302 (Tayman Medical). The "51O(k) "Substantial Equivalence" Decision-Making Process (Detailed) from O…	Nucletron Corp.	2000	—
*	K963302	Tayman Medical, Inc. Stepping & Stabilizing System Summary page 1 …eknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270 (Nucletron Corp.) and K-963302 (Tayman Medical). The "51O(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 …e intended uses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process under K972152 (Devmed, Inc.), KO11581 (Amertek Inc.), 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 K972152: 2 other devices →

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 3 companies; a new generation was cleared every 3.9 years on median.
1 of the 12 ancestors has a recall of any class.
2 other devices also cite its predicate K972152.

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 major intended use of the Amertek Sure-Point Trackerm is the same as that of its unmodified predecessors cleared in KO11581 and K972152: to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. The Amertek Sure-Point TrackerTMalso allows data from the use of probe location indicators to be fed directly into the brachytherapy…

Read the full statement (119 words)

Like other basic stabilizers and steppers (e.9. Barzell-Whitmore Omnistand; Tayman Accuguide; Teknar, Proscan), this device is applicable in other surgical procedures or specialties which require accurate instrument fixation, such as cryosurgery, biopsy, and remote afterloading equipment (HDR) such as that used with the Nucletron device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030518: Ameritek Sure-Point Tracker System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030518

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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