510(k) · Cleared

Cleared

HDR Contour TP Template and Implant Accessories

K993400510(k) TraditionalCleared Jan 6, 200090-day reviewClass II21 CFR 892.5700

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

Mick Radio-Nuclear Instruments, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Jan 6, 2000 as substantially equivalent to K910862 (Best Industries, 1991) and 6 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.

Decided: Jan 6, 2000
Review: 90 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K811280 (1981). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK811280 Flex-TemplateMick Radio-Nuclear Instruments, Inc. · 1981
This deviceK993400 HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000
Descendant · cites it directly · 0 of its ownK150979 CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
Descendant · cites it directly · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016 · cites it directly0descendants
K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K811280	Flex-Template	Mick Radio-Nuclear Instruments, Inc.	1981	—
0 (this device)	K993400	HDR Contour TP Template and Implant Accessories	Mick Radio-Nuclear Instruments, Inc.	2000	—
+1	K150979	CT/MR Compatible M.A.C. Interstitial GYN Template	Mick Radio-Nuclear Instruments, Inc.	2016	—
+1	K031273	Ameritek Sure-Point HDR Needle Template	Amertek Medical, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1991	1	0
1992	1	0
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2016	1	0

FIG. 1 — Lineage of K993400, 1981–2016Source: 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 JAQ? 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 JAQ device

#1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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? (7)

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
*	K910862	Various Template Applicators Summary page 1 …Inc. 1470 Outlook Avenue Bronx, New York 10465 Name of Predicate Devices: ¢y Device Manufacturer K Number Template \| Best Industries Syed/Neblett Prostate Template K910862 Mick Radio-Nuclear Instruments, Inc. Flex- \| K811280 Template Needles Best Industries Flexi-Needle K933410 Mick Radio-Nuclear…	Best Industries	1991	—
*	K811280	Flex-Template Summary page 1 …of Predicate Devices: ¢y Device Manufacturer K Number Template \| Best Industries Syed/Neblett Prostate Template K910862 Mick Radio-Nuclear Instruments, Inc. Flex- \| K811280 Template Needles Best Industries Flexi-Needle K933410 Mick Radio-Nuclear Instruments, Inc. Mick 200- \| K890341 TP and Mick TP N…	Mick Radio-Nuclear Instruments, Inc.	1981	—
*	K933410	Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of… Summary page 1 …Template \| Best Industries Syed/Neblett Prostate Template K910862 Mick Radio-Nuclear Instruments, Inc. Flex- \| K811280 Template Needles Best Industries Flexi-Needle K933410 Mick Radio-Nuclear Instruments, Inc. Mick 200- \| K890341 TP and Mick TP Needle Needle Technologies Seed Implant Needle K921886 Mi…	Best Industries	1994	—
*	K890341	Mick 200-TP and Mick TP Needle Summary page 1 …te K910862 Mick Radio-Nuclear Instruments, Inc. Flex- \| K811280 Template Needles Best Industries Flexi-Needle K933410 Mick Radio-Nuclear Instruments, Inc. Mick 200- \| K890341 TP and Mick TP Needle Needle Technologies Seed Implant Needle K921886 Mick Radio-Nuclear Instruments, Inc. H AM. \| K961601 Applic…	Mick Radio-Nuclear Instruments, Inc.	1989	1
*	K921886	Needle Technologies Seed Implant Needle Summary page 1 …late Needles Best Industries Flexi-Needle K933410 Mick Radio-Nuclear Instruments, Inc. Mick 200- \| K890341 TP and Mick TP Needle Needle Technologies Seed Implant Needle K921886 Mick Radio-Nuclear Instruments, Inc. H AM. \| K961601 Applicator Leg Huestis Medical Flexi-Board K904005 Support Any statement…	Needle Technologies, Inc.	1992	—
*	K961601	H.a.M. Applicator Summary page 1 …ck Radio-Nuclear Instruments, Inc. Mick 200- \| K890341 TP and Mick TP Needle Needle Technologies Seed Implant Needle K921886 Mick Radio-Nuclear Instruments, Inc. H AM. \| K961601 Applicator Leg Huestis Medical Flexi-Board K904005 Support Any statement made in conjunction with this submission regarding su…	Mick Radio-Nuclear Instruments, Inc.	1996	—
*	K904005	Huestis Flexi-Board Summary page 1 …41 TP and Mick TP Needle Needle Technologies Seed Implant Needle K921886 Mick Radio-Nuclear Instruments, Inc. H AM. \| K961601 Applicator Leg Huestis Medical Flexi-Board K904005 Support Any statement made in conjunction with this submission regarding substantial equivalence to any other product only rela…	Huestis Machine Corp.	1990	—

Also cleared against K910862: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K150979	CT/MR Compatible M.A.C. Interstitial GYN Template	Mick Radio-Nuclear Instruments, Inc.	2016	0
K031273	Ameritek Sure-Point HDR Needle Template	Amertek Medical, Inc.	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 7 ancestors has a recall of any class.
Of its descendants, K150979 (Mick Radio-Nuclear Instruments, Inc., 2016) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K910862.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAQ

6in 2025

2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007high 252 (2018) · low 27 (2009)2026

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

Recalls per year · JAQ

1in 2019

2007high 13 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JAQ

3in 2025

2007high 43 (2013) · low 1 (2024)2025

MAUDE reports naming product code JAQ, 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	11	48	0	13
2008	10	34	5	32
2009	10	27	1	35
2010	2	—	2	36
2011	2	—	13	42
2012	7	89	5	34
2013	6	100	1	43
2014	7	116	0	18
2015	11	183	0	7
2016	6	154	0	3
2017	7	229	0	5
2018	7	252	0	2
2019	2	—	1	8
2020	4	62	0	8
2021	0	—	0	5
2022	1	—	0	5
2023	2	—	0	3
2024	10	126	0	1
2025	6	91	0	3
2026	2	—	3	—

What is it indicated for?

Read the full statement (115 words)

The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading. One common use of high dose rate remote afterloaders is in the treatment of cancer of the prostate. The system described in this 510(k) has been developed to work with commercially available high dose rate remote in the treatment of the Prostate.

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/K993400 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993400: HDR Contour TP Template and Implant Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993400

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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