510(k) · Cleared
ClearedCapri Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivaray, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 3, 2009 as substantially equivalent to K061241 (Biolucent, Inc., 2006) and 1 other predicate after a 50-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 3, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K864210 (1986). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- 2 generations backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- 1 generation backK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- This deviceK092822 Capri ApplicatorVivaray, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK133922 Gentlecare AR ApplicatorGc Medtech, LLC · 2014
- Descendant · cites it directly · 0 of its ownK120344 Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012
Most influential descendants
Showing 2 of 2 · See allView 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 | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| −2 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| −1 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| 0 (this device) | K092822 | Capri Applicator | Vivaray, Inc. | 2009 | — |
| +1 | K133922 | Gentlecare AR Applicator | Gc Medtech, LLC | 2014 | — |
| +1 | K120344 | Radiapak Brachytherapy Applicator Balloon Device | Radiadyne, LLC (Specification Developer) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K061241 | Biolucent Applicator, Model Rta-XXSummary page 1…892.5700 DEVICE Class II CLASSIFICATION: PRODUCT CODE JAQ PREDICATE DEVICES: BioLucent's Applicator (K061241) Nucletron's Miami Applicator (K953946) Substantially Equivalent To: The CAPRI Applicator is substantial… | 2006 |
| * | K953946 | Microselectron-HDR Version 2Summary page 1…s II CLASSIFICATION: PRODUCT CODE JAQ PREDICATE DEVICES: BioLucent's Applicator (K061241) Nucletron's Miami Applicator (K953946) Substantially Equivalent To: The CAPRI Applicator is substantially equivalent in intended use, principal of operation and tech… | 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 23 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K133922 (Gc Medtech, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061241.
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. 2009, 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?
The CAPRITM Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092822: Capri Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092822
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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