510(k) · Cleared
ClearedH.a.M. Applicator
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 23, 1996 after a 242-day review. The FDA summary names no predicate by number. 28 later devices descend from it.
- Decided
- Dec 23, 1996
- Review
- 242 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 6 citing it directly.
- This deviceK961601 H.a.M. ApplicatorMick Radio-Nuclear Instruments, Inc. · 1996
- Descendant · cites it directly · 17 of its ownK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 3 generations on · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 4 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006 · cites it directly17descendants
- K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · 2 generations on13descendants
- K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on12descendants
- K081677Savi Applicator KitCianna Medical, Inc. · 2008 · 3 generations on11descendants
- K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961601 | H.a.M. Applicator | Mick Radio-Nuclear Instruments, Inc. | 1996 | — |
| +1 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| +2 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| +2 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +3 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +4 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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?
The FDA summary names no predicate by number.
What descends from it? (28)
See all 286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061241 | Biolucent Applicator, Model Rta-XX | 2006 | 17 |
| K063382 | HDR CT Compatible Split Ring Applicator | 2006 | 2 |
| K993400 | HDR Contour TP Template and Implant Accessories | 2000 | 2 |
| K983338 | Freiburg Flap Applicator Set, Part Number 089.095 | 1999 | 2 |
| K060299 | Art Brachytherapy Applicator | 2006 | 1 |
| K052351 | HDR Iort Shielded Applicator | 2005 | 1 |
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?
- Of its descendants, K061241 (Biolucent, Inc., 2006) has gone furthest, with 17 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.
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 H.A.M. Applicator is intended to be used as an accessory to high-dose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961601: H.a.M. Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961601
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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