510(k) · Decided
DecidedSavi Applicator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cianna Medical, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 22, 2008 as substantially equivalent to K080565 (Cianna Medical, Inc., 2008) and 3 other predicates after a 35-day review. Its family tree reaches back 7 generations to 1986. 11 later devices descend from it.
- Decided
- Jul 22, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K864210 (1986). 15 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 6 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 5 generations backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- 4 generations backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- 3 generations backK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- 2 generations backK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- 1 generation backK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- This deviceK081677 Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · 4 generations on · 4 of its ownK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- Descendant · 5 generations on · 3 of its ownK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · cites it directly9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 2 generations on8descendants
- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 3 generations on5descendants
- K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016 · 4 generations on4descendants
- K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −6 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −5 | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| −4 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| −3 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| −2 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| −1 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| 0 (this device) | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +1 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| +2 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +3 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +4 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| +5 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K080565 | Modification to: Savi Applicator KitSummary page 1…(JAQ), 21 CFR, 892.5700 Device Classification: Class II Predicate devices: SAVI Applicator (K080565) Wright Vaginal Cuff Applicator (K980601) Comfort Cathete… | 2008 |
| * | K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…Summary page 1…Classification: Class II Predicate devices: SAVI Applicator (K080565) Wright Vaginal Cuff Applicator (K980601) Comfort Catheters (K032372) Shielded Rectal Applicator S… | 1998 |
| * | K032372 | Nucletron Comfort Catheter System, Model 189.007Summary page 1…SAVI Applicator (K080565) Wright Vaginal Cuff Applicator (K980601) Comfort Catheters (K032372) Shielded Rectal Applicator Set (K033371) Manufacturer: Cianna Medica… | 2003 |
| * | K033371 | Varian Intracavitary Brachytherapy ApplicatorsSummary page 1…ght Vaginal Cuff Applicator (K980601) Comfort Catheters (K032372) Shielded Rectal Applicator Set (K033371) Manufacturer: Cianna Medical 6 Journey, Suite 125… | 2003 |
What descends from it? (11)
See all 112 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 22 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K091378 (Hologic, Inc., 2009) has gone furthest, with 9 descendants of its own.
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. 2008, 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 SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI 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/K081677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081677: Savi Applicator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081677
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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