510(k) · Cleared
ClearedHeyman Packing Applicator Set (GM11004580)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Aug 30, 2024 as substantially equivalent to K160045 (Varian Medical Systems, Inc., 2016) after a 107-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Aug 30, 2024
- Review
- 107 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912555 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 2 generations backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- 1 generation backK160045 Heyman Packing Applicator SetVarian Medical Systems, Inc. · 2016
- This deviceK241386 Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −2 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| −1 | K160045 | Heyman Packing Applicator Set | Varian Medical Systems, Inc. | 2016 | — |
| 0 (this device) | K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K160045 | Heyman Packing Applicator SetSummary page 4…ide Applicator System Regulation Number: §892.5700 Product Code: JAQ III. Predicate Device Heyman Packing Applicator Set (K160045) IV. Device Description The Heyman Packing Applicator Set consists of various sized Heyman-capsules which… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
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. 2024, 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 Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241386: Heyman Packing Applicator Set (GM11004580).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241386
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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