510(k) · Cleared
ClearedMammosite Cavity Evaluation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on May 9, 2008 as substantially equivalent to K011690 (Proxima Therapeutics, Inc., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 14 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, the oldest K853912 (1986). 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 backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 2 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 1 generation backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- This deviceK081179 Mammosite Cavity Evaluation DeviceHologic, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK092323 Contura Cavity Maintenance CatheterSenorx, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK101411 Savi Preparation DeviceCianna Medical, Inc. · 2010
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 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −2 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −1 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| 0 (this device) | K081179 | Mammosite Cavity Evaluation Device | Hologic, Inc. | 2008 | — |
| +1 | K092323 | Contura Cavity Maintenance Catheter | Senorx, Inc. | 2009 | — |
| +1 | K101411 | Savi Preparation Device | Cianna Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TraySummary page 2…spect to its predicate. Testing that pertains to design aspects that have remained unchanged will reference MammoSite 4-5cm RTS applicator (silicone) 510(k) filing K011690. The sterilized CED catheters and components were tested after gamma sterilization at 25-4OkGy exposure. The catheters wer… | 2002 |
| * | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TraySummary page 1…ation: 21 CFR 892.5700, Product Code JAQ Device Classification: Class II 3. Predicate Device: The MammoSite Radiation Therapy System (RTS) (KO1 1690 and K030558) has been selected as the predicate device for the MammoSite Cavity Evaluation Device (CED). 4. Device Description: The… | 2003 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K092323 (Senorx, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K011690.
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 MammoSite Cavity Evaluation Device (CED) may be used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite Radiation Therapy System (RTS) applicator. It may be used during surgery to assess skin spacing and conformance. The CED may also be left in the lumpectomy cavity as a placeholder until it is exchanged for the MammoSite RTS applicator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081179 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081179: Mammosite Cavity Evaluation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081179
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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