510(k) · Cleared
Recalled · Class II · 2017Intrabeam Needle Applicator
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 Apr 13, 2012 as substantially equivalent to K980526 (Pec Photoelectron Corp., 1998) and 1 other predicate after a 408-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 13, 2012
- Review
- 408 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964947 (1997). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964947 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1997
- 1 generation backK980526 Photon Radiosurgery System PRS400Pec Photoelectron Corp. · 1998
- This deviceK110590 Intrabeam Needle ApplicatorCarl Zeiss Surgical GmbH · 2012
- 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 |
|---|---|---|---|---|---|
| −2 | K964947 | Photon Radiosurgery System (PRS) | Photoelectron Corporation | 1997 | — |
| −1 | K980526 | Photon Radiosurgery System PRS400 | Pec Photoelectron Corp. | 1998 | — |
| 0 (this device) | K110590 | Intrabeam Needle Applicator | Carl Zeiss Surgical GmbH | 2012 | — |
| +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 |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K980526 | Photon Radiosurgery System PRS400Summary page 1…m Classification Name: System, Therapeutic, X-ray, (21 CER 892.5900) Product Code: 3. PREDICATE DEVICES *Photon Radiosurgery System PRS 400 System, K980526 *INTRABEAM®9 System with Balloon Applicator, most recently cleared in K090584 4. DEVICE DESCRIPTION P… | 1998 |
| * | K090584 | Intrabeam System with Balloon Applicator and CBG SetsSummary page 1…REDICATE DEVICES *Photon Radiosurgery System PRS 400 System, K980526 *INTRABEAM®9 System with Balloon Applicator, most recently cleared in K090584 4. DEVICE DESCRIPTION Physical Description The proposed device is a modification of the INTRABEAM®R System with Ba… | 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 15 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K162568 (Carl Zeiss Meditec, AG, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K980526.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Needle Applicator set (comprising the Needle Applicator and guide shaft) is indicated for use in combination with the INTRABEAM System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110590 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110590: Intrabeam Needle Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110590
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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