510(k) · Cleared
ClearedSwift 2.0, Model 132.001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Aug 7, 2003 as substantially equivalent to K022739 (Nucletron Corporation, 2002) after a 118-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 7, 2003
- Review
- 118 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911612 (1991). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- 2 generations backK992303 Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp. · 2000
- 1 generation backK022739 Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model…Nucletron Corporation · 2002
- This deviceK031158 Swift 2.0, Model 132.001Nucletron Corp. · 2003
- Descendant · cites it directly · 1 of its ownK112420 Oncentra Prostate 4.0Nucletron · 2011
- Descendant · 2 generations on · 0 of its ownK170841 BiopSee, Mobile USMedcom GmbH · 2017
- Descendant · cites it directly · 0 of its ownK080929 Oncentra GynNucletron Corporation · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| −2 | K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 | Nucletron Corp. | 2000 | — |
| −1 | K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 | Nucletron Corporation | 2002 | — |
| 0 (this device) | K031158 | Swift 2.0, Model 132.001 | Nucletron Corp. | 2003 | — |
| +1 | K112420 | Oncentra Prostate 4.0 | Nucletron | 2011 | — |
| +2 | K170841 | BiopSee, Mobile US | Medcom GmbH | 2017 | — |
| +1 | K080929 | Oncentra Gyn | Nucletron Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002Summary page 2…on for the specified loading. From this the information the patient can be treated with the dwell positions of the source. Modificationsto the previously cleared device K022739, have been made to add functionality for: 0 Encoder 3D Ultrasound acquisition 3D VOI contouring 3D Catheter recognition I… | 2002 |
What descends from it? (3)
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 12 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112420 (Nucletron, 2011) has gone furthest, with 1 descendant 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.
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?
Swift is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031158: Swift 2.0, Model 132.001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031158
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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