510(k) · Cleared
ClearedCT Compatible F/S/D Applicators
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 Dec 22, 2006 as substantially equivalent to K955844 (Varian Assoc., Inc., 1996) and 3 other predicates after a 44-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.
- Decided
- Dec 22, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K864210 (1986). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 2 generations backK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001 · Recalled
- 1 generation backK030110 CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003 · Recalled
- This deviceK063381 CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −3 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −2 | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2001 | 2 |
| −1 | K030110 | CT HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2003 | 1 |
| 0 (this device) | K063381 | CT Compatible F/S/D Applicators | Mick Radio-Nuclear Instruments, Inc. | 2006 | — |
| +1 | 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 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K955844 | Applicators for Varian Varisource Remote High Dose Rate AfterloaderSummary page 1…ce Manufacturer K Number Applicators for Varian Varisource Varian Associates, Inc. K955844 Remote High Dose Rate Afterloaders OMNITRON Gyn Applicator OMINITRON Intl, Inc.… | 1996 |
| * | K913908 | Omnitron Gyn Applicator SystemSummary page 1…Inc. K955844 Remote High Dose Rate Afterloaders OMNITRON Gyn Applicator OMINITRON Intl, Inc. K9 13908 System CT HDR Tandem / Ring Mick Radio-Nuclear Instruments, K0301 10 Applicat… | 1992 |
| * | K030110 | CT HDR Tandem/Ring Applicator with Rectal RetractorSummary page 1…tor OMINITRON Intl, Inc. K9 13908 System CT HDR Tandem / Ring Mick Radio-Nuclear Instruments, K0301 10 Applicator with Rectal Refractor Inc. I-DR Compatible Tandem & Mick Radio-Nuclear Instru… | 2003 |
| * | K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorSummary page 2…dio-Nuclear Instruments, K030110 Applicator with Rectal Retractor Inc. HDR Compatible Tandem & Mick Radio-Nuclear Instruments, K040704 Ovoid Applicators Inc. The delivery of radiation therapy via high dose rate Brachytherapy treatmen… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators… | 2020 | 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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K200221 (Mick Radio-Nuclear Instruments, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K955844.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063381 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063381: CT Compatible F/S/D Applicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063381
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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