510(k) · Cleared
Recalled · 2008Interplant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burdette Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 1, 1999 as substantially equivalent to K924240 (Small Systems Group, Inc., 1993) and 3 other predicates after a 241-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 1, 1999
- Review
- 241 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K850571 (1985). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK850571 I-125 Implant GunMick Radio-Nuclear Instruments, Inc. · 1985
- 1 generation backK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
- This deviceK982696 InterplantBurdette Medical Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK131428 RadvisionAcoustic Medsystems, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131428RadvisionAcoustic Medsystems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850571 | I-125 Implant Gun | Mick Radio-Nuclear Instruments, Inc. | 1985 | — |
| −1 | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand… | Barzell-Whitmore Maroon Bells, Inc. | 1997 | — |
| 0 (this device) | K982696 | Interplant | Burdette Medical Systems, Inc. | 1999 | — |
| +1 | K131428 | Radvision | Acoustic Medsystems, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K924240 | Prowess 2000Summary page 1…system Class 11 Substantial equivalence claimed to: Multimedia Medical Systems, Inc. B3DTUA TherapacPLUS dose planning SSGI Prowess 500 and Prowess 2000 dose planning K924240 CIVCO Medical Instruments Ultra-Step stepper K875241 B&K Medical Systems HP-100 stepper/stand Tayman Medical Accuseed stand/st… | 1993 |
| * | K875241 | Civco Seed Implant Needle GuideSummary page 1…Multimedia Medical Systems, Inc. B3DTUA TherapacPLUS dose planning SSGI Prowess 500 and Prowess 2000 dose planning K924240 CIVCO Medical Instruments Ultra-Step stepper K875241 B&K Medical Systems HP-100 stepper/stand Tayman Medical Accuseed stand/stabilizer K963302 COTAN stand/stabilizer Northwest st… | 1988 |
| * | K963302 | Tayman Medical, Inc. Stepping & Stabilizing SystemSummary page 1…wess 2000 dose planning K924240 CIVCO Medical Instruments Ultra-Step stepper K875241 B&K Medical Systems HP-100 stepper/stand Tayman Medical Accuseed stand/stabilizer K963302 COTAN stand/stabilizer Northwest stand/stabilizer Maroon Bels, Inc. Brachystand and Brachystepper K972672 PN Dh WD - Descrip… | 1997 |
| * | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Summary page 1…-100 stepper/stand Tayman Medical Accuseed stand/stabilizer K963302 COTAN stand/stabilizer Northwest stand/stabilizer Maroon Bels, Inc. Brachystand and Brachystepper K972672 PN Dh WD - Description: The Interplant™ system for brachytherapy was developed to address the need for a comprehensive system… | 1997 |
| * | — | Multimedia Medical Systems, Inc. B3DTUA TherapacPLUS dose planning Named without a submission number | |
| * | — | B&K Medical Systems HP-100 stepper/stand Named without a submission number | |
| * | — | COTAN stand/stabilizer Named without a submission number | |
| * | — | Northwest stand/stabilizer Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131428 | Radvision | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2008 | Not classified | Z-2622-2011 | Software design | Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K131428 (Acoustic Medsystems, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K924240.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The Burdette Medical Systems, Inc. Interplant™ system is used in planning and performing a prostate brachytherapy implant procedure to provide ultrasound probe alignment and radioactive seed implantation. The Interplant™ device will use standard 125-Todine (*** I) or 103-Paladium (‘*’ Pd) isotope permanent implant radiation seeds for the treatment of prostate cancer. The system will allow volume measurement and dose calculation, relevant prostate anatomy and dose visualization, and post-treatment seed localization.
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/K982696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982696: Interplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982696
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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