510(k) · Cleared
Recalled · Class II · 2017Intrabeam System with Balloon Applicator and CBG Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Surgical GmbH · JAD System, Therapeutic, X-Ray
Cleared on Nov 24, 2009 after a 266-day review. The FDA summary names no predicate by number. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 24, 2009
- Review
- 266 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 5
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK090584 Intrabeam System with Balloon Applicator and CBG SetsCarl Zeiss Surgical GmbH · 2009
- Descendant · cites it directly · 2 of its ownK110590 Intrabeam Needle ApplicatorCarl Zeiss Surgical GmbH · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
- Descendant · 2 generations on · 0 of its ownK241174 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM…Carl Zeiss Meditec, AG · 2025
Most influential descendants
Showing 3 of 3 · See all- K110590Intrabeam Needle ApplicatorCarl Zeiss Surgical GmbH · 2012 · cites it directly2descendants
- K162568Intrabeam 600Carl Zeiss Meditec, AG · 2016 · cites it directly1descendant
- K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090584 | Intrabeam System with Balloon Applicator and CBG Sets | Carl Zeiss Surgical GmbH | 2009 | — |
| +1 | K110590 | Intrabeam Needle Applicator | Carl Zeiss Surgical GmbH | 2012 | 1 |
| +1 | K162568 | Intrabeam 600 | Carl Zeiss Meditec, AG | 2016 | — |
| +2 | K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART… | Carl Zeiss Meditec, AG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 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 JAD? 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 JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 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? (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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2017 | Class II | Z-0001-2018 | Process control | The device had an incorrect printed calibration value on the calibration certificate. |
| Oct 25, 2012 | Class II | Z-0404-2013 | Nonconforming Material/Component | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Oct 25, 2012 | Class II | Z-0405-2013 | Nonconforming Material/Component | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Oct 25, 2012 | Class II | Z-0406-2013 | Nonconforming Material/Component | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Jul 1, 2011 | Not classified | Z-2989-2011 | Process control | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol, |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110590 (Carl Zeiss Surgical GmbH, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use. with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavitary or intraoperative radiotherapy treatments. The INTRABEAM® Balloon Applicator together with the LNTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
The safety and effectiveness of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090584: Intrabeam System with Balloon Applicator and CBG Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090584
Report an extraction error
Are you the manufacturer?
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