510(k) · Cleared
ClearedMini Mick Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mick Radio-Nuclear Instruments, Inc. · JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Cleared on Oct 23, 1980 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 23, 1980
- Review
- 62 days
- Class
- Class II
- Product code
- JWJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK802032 Mini Mick ApplicatorMick Radio-Nuclear Instruments, Inc. · 1980
- Descendant · cites it directly · 4 of its ownK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
- Descendant · cites it directly · 3 of its ownK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK030518 Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK024183 Alton PT StepperAlton Design, LLC · 2003
Most influential descendants
Showing 5 of 5 · See all- K972152Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997 · cites it directly4descendants
- K011581Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001 · cites it directly3descendants
- K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · 2 generations on0descendants
- K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003 · cites it directly0descendants
- K024183Alton PT StepperAlton Design, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802032 | Mini Mick Applicator | Mick Radio-Nuclear Instruments, Inc. | 1980 | — |
| +1 | K972152 | Devmed Stepping and Stabilizing System | Devmed Corp. | 1997 | — |
| +1 | K011581 | Ameritek Brachytherapy Template | Amertek Medical, Inc. | 2001 | — |
| +2 | K031273 | Ameritek Sure-Point HDR Needle Template | Amertek Medical, Inc. | 2003 | — |
| +1 | K030518 | Ameritek Sure-Point Tracker System | Amertek Medical, Inc. | 2003 | — |
| +1 | K024183 | Alton PT Stepper | Alton Design, LLC | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 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 JWJ? 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 JWJ device
- #1 K233574 Total Wrist Arthroplasty System (TWA)score 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K972152 (Devmed Corp., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JWJ devicesJWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWJ
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JWJ
196in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWJ
No recall names JWJ since 2007.
Adverse event reports per year · JWJ
8in 2025
MAUDE reports naming product code JWJ, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 48 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 127 |
| 2020 | 2 | — | 0 | 34 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 65 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 3 | 196 | 0 | 18 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K802032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K802032: Mini Mick Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K802032
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026