510(k) · Cleared
Recalled · Class II · 2017Intrabeam Flat Applicator, Intrabeam Surface Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Jun 26, 2013 as substantially equivalent to K083734 (Xoft, Inc., 2009) after a 114-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 26, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864210 (1986). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 2 generations backK073107 Valencia Skin Applicator Set, Model: 189.701Nucletron Corporation · 2007
- 1 generation backK083734 Axxent Surface Applicator, Model 710257Xoft, Inc. · 2009
- This deviceK130549 Intrabeam Flat Applicator, Intrabeam Surface ApplicatorCarl Zeiss Meditec, Inc. · 2013
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −3 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −2 | K073107 | Valencia Skin Applicator Set, Model: 189.701 | Nucletron Corporation | 2007 | — |
| −1 | K083734 | Axxent Surface Applicator, Model 710257 | Xoft, Inc. | 2009 | — |
| 0 (this device) | K130549 | Intrabeam Flat Applicator, Intrabeam Surface Applicator | Carl Zeiss Meditec, Inc. | 2013 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083734 | Axxent Surface Applicator, Model 710257Summary page 1…name: System, Therapeutic, X-ray Classification: Class 11 (21 CFR 892.5900) Product Code: JAD Predicate Device Company: - Xoft, Inc. Device: Axxent® Surface Applicator, K083734 Carl Zeiss Meditec INTRABEAM Flat and Surface Applicators Premarket Notification 510(k) March 2013 Intended Use… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162568 | Intrabeam 600 | 2016 | 1 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K162568 (Carl Zeiss Meditec, AG, 2016) has gone furthest, with 1 descendant 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. 2013, 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® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System.
During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
During treatment of tumors on the body surface.
The INTRABEAM® Surface Applicator is designed to deliver a flat radiation field directly at the applicator’s surface.
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/K130549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130549: Intrabeam Flat Applicator, Intrabeam Surface Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130549
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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