510(k) · Cleared
ClearedHDR Miami Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mick Radio-Nuclear Instruments, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 8, 2002 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) after an 80-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Apr 8, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864210 (1986). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- This deviceK020176 HDR Miami ApplicatorMick Radio-Nuclear Instruments, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK150979 CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See all- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · cites it directly0descendants
- K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K020176 | HDR Miami Applicator | Mick Radio-Nuclear Instruments, Inc. | 2002 | — |
| +1 | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid… | Mick Radio-Nuclear Instruments, Inc. | 2020 | — |
| +1 | K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | Mick Radio-Nuclear Instruments, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K953946 | Microselectron-HDR Version 2Summary page 1…dio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, New York 10550 Name of Predicate Devices: (1) Manufacturer K Number Nucletron Miami Vaginal Applicator K953946 Any statement made in conjunction with this submission regarding . substantial equivalence to any other product only relates to… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200221 (Mick Radio-Nuclear Instruments, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 27 other devices also cite its predicate K953946.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 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?
This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diamter sleeves and interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.
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/K020176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020176: HDR Miami Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020176
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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