510(k) · Cleared
Recalled · Class II · 2012HDR Tandem/Ring 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 Aug 27, 2001 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) after a 90-day review. Its family tree reaches back 2 generations to 1986. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 27, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864210 (1986). 3 ancestors in all. 13 later devices descend from it, 4 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 deviceK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK030110 CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK150839 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring…Varian Medical Systems, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK123912 Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator…Spencer Fillmore · 2013
- Descendant · 2 generations on · 2 of its ownK122840 CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK063382 HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K030110CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003 · cites it directly9descendants
- K1508393D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring…Varian Medical Systems, Inc. · 2015 · 2 generations on2descendants
- K123912Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetSpencer Fillmore · 2013 · cites it directly2descendants
- K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc. · 2012 · 2 generations on2descendants
- K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006 · cites it directly2descendants
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) | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2001 | — |
| +1 | K030110 | CT HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2003 | 1 |
| +2 | K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set… | Varian Medical Systems, Inc. | 2015 | — |
| +1 | K123912 | Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set | Spencer Fillmore | 2013 | — |
| +2 | K122840 | CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407 | Mick Radio-Nuclear Instruments, Inc. | 2012 | — |
| +1 | K063382 | HDR CT Compatible Split Ring Applicator | Mick Radio-Nuclear Instruments, Inc. | 2006 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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…ents, Inc. 521 Homestead Avenue Mount Vernon, New York 10550 Name of Predicate Devices: (M) Manufacturer K Number Nucletron Corporation Ring Applicator - Complete | K953946 Set Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates t… | 1996 |
What descends from it? (13)
See all 134 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2012 | Class II | Z-0760-2013 | Component design/selection | A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. |
| Apr 12, 2012 | Class II | Z-0759-2013 | Component design/selection | A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 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, K030110 (Mick Radio-Nuclear Instruments, Inc., 2003) has gone furthest, with 9 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?
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…
Read the full statement (179 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 (Brachytherapy). One common application of Brachytherapy is in the treatment of cancer of the cervix. 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 HDR Tandem/Ring Applicator with Rectal Retractor is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Ring Applicator, K953946) and with a rectal retractor and varying intrauterine tube length diameters, clinical needs can be best optimized along with minimization of dose to the rectum.
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/K011657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011657: HDR Tandem/Ring Applicator with Rectal Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026