510(k) · Cleared
ClearedI-125 Implant Gun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mick Radio-Nuclear Instruments, Inc. · IWJ System, Applicator, Radionuclide, Manual
Cleared on Mar 26, 1985 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 26, 1985
- Review
- 41 days
- Class
- Class I
- Product code
- IWJ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK850571 I-125 Implant GunMick Radio-Nuclear Instruments, Inc. · 1985
- Descendant · cites it directly · 6 of its ownK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK131161 EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper…CIVCO Medical Instruments Co., Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK982696 InterplantBurdette Medical Systems, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 0 of its ownK171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and…Koelis · 2017
- Descendant · 3 generations on · 0 of its ownK131428 RadvisionAcoustic Medsystems, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Barzell-Whitmore Maroon Bells, Inc. · 1997 · cites it directly6descendants
- K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc. · 2013 · 2 generations on1descendant
- K982696InterplantBurdette Medical Systems, Inc. · 1999 · 2 generations on1descendant
- K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis · 2017 · 3 generations on0descendants
- K131428RadvisionAcoustic Medsystems, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K131161 | EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch… | CIVCO Medical Instruments Co., Inc. | 2013 | — |
| +2 | K982696 | Interplant | Burdette Medical Systems, Inc. | 1999 | 1 |
| +3 | K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD… | Koelis | 2017 | — |
| +3 | K131428 | Radvision | Acoustic Medsystems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support… | 1997 | 6 |
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?
- Of its descendants, K972672 (Barzell-Whitmore Maroon Bells, Inc., 1997) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IWJ devicesIWJ System, Applicator, Radionuclide, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWJ
FDA has decided no IWJ device since 2007.
Median 510(k) review, days · IWJ
Too few IWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · IWJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWJ
40in 2025
MAUDE reports naming product code IWJ, 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 | 0 | — | 5 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 2 | 3 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K850571 · printed Nov 3, 2026
Cite this page
510(k) Report. “K850571: I-125 Implant Gun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K850571
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026