510(k) · Cleared
ClearedCT-Compatible Fletcher System Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
University of Michigan · IWJ System, Applicator, Radionuclide, Manual
Cleared on Oct 1, 1990 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 58 later devices descend from it.
- Decided
- Oct 1, 1990
- Review
- 62 days
- Class
- Class I
- Product code
- IWJ
- Recalls
- None
- Predicates
- 0
58 later devices descend from it, 1 citing it directly.
- This deviceK903403 CT-Compatible Fletcher System ApplicatorUniversity of Michigan · 1990
- Descendant · cites it directly · 57 of its ownK940663 Peacock PlanNomos Corp. · 1996
- Descendant · 2 generations on · 27 of its ownK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- Descendant · 3 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
- Descendant · 4 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K940663Peacock PlanNomos Corp. · 1996 · cites it directly57descendants
- K984532Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999 · 2 generations on27descendants
- K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999 · 2 generations on24descendants
- K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001 · 3 generations on23descendants
- K020971DCM 2.0Mds Nordion AB · 2002 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903403 | CT-Compatible Fletcher System Applicator | University of Michigan | 1990 | — |
| +1 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| +2 | K984532 | Cadplan Helios Option 6.0 | Varian Medical Systems, Inc. | 1999 | — |
| +2 | K993766 | Helax-TMS V 5.0 Radiation Therapy Treatment Planning System | Helax AB | 1999 | — |
| +3 | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | Mds Nordion | 2001 | — |
| +4 | K020971 | DCM 2.0 | Mds Nordion AB | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K940663 | Peacock Plan | 1996 | 57 |
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, K940663 (Nomos Corp., 1996) has gone furthest, with 57 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/K903403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K903403: CT-Compatible Fletcher System Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903403
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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