510(k) · Cleared
ClearedIndigo Prostate Seeding Needle Cartridge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indigo Medical, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Oct 4, 1999 as substantially equivalent to K890341 (Mick Radio-Nuclear Instruments, Inc., 1989) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 4, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890341 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK890341 Mick 200-TP and Mick TP NeedleMick Radio-Nuclear Instruments, Inc. · 1989 · Recalled
- This deviceK992262 Indigo Prostate Seeding Needle Cartridge SystemIndigo Medical, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890341 | Mick 200-TP and Mick TP Needle | Mick Radio-Nuclear Instruments, Inc. | 1989 | 1 |
| 0 (this device) | K992262 | Indigo Prostate Seeding Needle Cartridge System | Indigo Medical, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 KXK? 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 KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K890341 | Mick 200-TP and Mick TP NeedleSummary page 1…The predicate device to the Indigo Prostate Seeding Needle Cartridge is the Mick seed magazine used in conjunction with the Mick ™ 200-TP Applicator cleared under 510(k) K890341. The predicate devices to the indigo Seed. Spacer are I-125 Rapid Strand™, cleared under K940632, and LOOK, Inc. Spacing Material… | 1989 |
| * | K940632 | I-125 Rapid StrandSummary page 1…ed in conjunction with the Mick ™ 200-TP Applicator cleared under 510(k) K890341. The predicate devices to the indigo Seed. Spacer are I-125 Rapid Strand™, cleared under K940632, and LOOK, Inc. Spacing Material, 510(k) number unknown. Device Description: The Indigo Prostate Seeding Needle Cartridge System… | 1994 |
| * | — | LOOK, Inc. Spacing Material Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K890341.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, 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 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostatc gland for the treatment of localized tumors which arc of low to moderate radiosensitivity.
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/K992262 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992262: Indigo Prostate Seeding Needle Cartridge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992262
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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