510(k) · Cleared
ClearedCT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
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 Feb 28, 2020 as substantially equivalent to K993472 (Mick Radio-Nuclear Instruments, Inc., 2000) and 6 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Feb 28, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K864210 (1986). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 3 generations backK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001 · Recalled
- 2 generations backK030110 CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003 · Recalled
- 1 generation backK063381 CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006
- This deviceK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −4 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −3 | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2001 | 2 |
| −2 | K030110 | CT HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2003 | 1 |
| −1 | K063381 | CT Compatible F/S/D Applicators | Mick Radio-Nuclear Instruments, Inc. | 2006 | — |
| 0 (this device) | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid… | Mick Radio-Nuclear Instruments, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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? (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 | Decided |
|---|---|---|---|
| * | K993472 | Segmented Vaginal ApplicatorSummary page 7…Review Panel 510(k) # Number Classification Code K993472 Segmented Vaginal Applicator 21 CFR 892.5700 Class II JAQ Radiology K020176… | 2000 |
| * | K020176 | HDR Miami ApplicatorSummary page 7…Number Classification Code K993472 Segmented Vaginal Applicator 21 CFR 892.5700 Class II JAQ Radiology K020176 HDR Miami Applicator HDR Brachytherapy Applicator 21 CFR 892.5700 Class II JAQ Radiology K040704 H… | 2002 |
| * | K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorSummary page 7…700 Class II JAQ Radiology K020176 HDR Miami Applicator HDR Brachytherapy Applicator 21 CFR 892.5700 Class II JAQ Radiology K040704 HDR Compatible Tandem and Ovoid Applicators (Henschke) 21 CFR 892.5700 Class II JAQ Radiology K063381… | 2004 |
| * | K063381 | CT Compatible F/S/D ApplicatorsSummary page 7…00 Class II JAQ Radiology K040704 HDR Compatible Tandem and Ovoid Applicators (Henschke) 21 CFR 892.5700 Class II JAQ Radiology K063381 CT F/S/D Compatible Applicators 21 CFR 892.5700 Class II JAQ Radiology K063382… | 2006 |
| * | K063382 | HDR CT Compatible Split Ring ApplicatorSummary page 7…00 Class II JAQ Radiology K063381 CT F/S/D Compatible Applicators 21 CFR 892.5700 Class II JAQ Radiology K063382 HDR CT Compatible Split Ring Applicator 21 CFR 892.5700 Class II JAQ Radiology K122840… | 2006 |
| * | K122840 | CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Summary page 7…700 Class II JAQ Radiology K063382 HDR CT Compatible Split Ring Applicator 21 CFR 892.5700 Class II JAQ Radiology K122840 CT HDR Tandem/Ring Applicator with Rectal Retractor 21 CFR 892.5700 Class II JAQ Radiology K871216… | 2012 |
| * | K871216 | Hilaris-Nori Endometrial ApplicatorSummary page 7…00 Class II JAQ Radiology K122840 CT HDR Tandem/Ring Applicator with Rectal Retractor 21 CFR 892.5700 Class II JAQ Radiology K871216 2/3 Endometrial Applicator Sets 21 CFR 892.5650 Class I IWJ Radiology 3. Rea… | 1987 |
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 34 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 5 of the 22 ancestors have a recall of any class.
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. 2020, this device’s year, is highlighted.
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?
2/3 Endometrial Applicator Sets: A manual radionuclide applicator system, a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Segmented Vaginal Applicator: The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modem era Radiation Therapy has developed delivery systems using isotopes of Cesium…
Read the full statement (391 words)
2/3 Endometrial Applicator Sets: A manual radionuclide applicator system, a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy.
Segmented Vaginal Applicator: The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modem era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors are now treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities of this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common use of Brachytherapy is in the treatment of cancer of the vaginal process. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina.
HDR Miami Applicator: This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891l3l /A) which uses a single radioactive source of lridium-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 diameter sleeves and intrauterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.
HDR Compatible Tandem and Ovoid Applicators: The applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intra-cavitary treatment of cancer of the vagina and cervix.
CT Compatible F/S/D Applicators: CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.
HDR CT Compatible Split Ring Applicator: The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.
CCT HDR Tandem Ring Applicator with Rectal Retractor: The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200221: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200221
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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