510(k) · Cleared
ClearedImplanters/Adjustable/Anderson's Markers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Industries · IWJ System, Applicator, Radionuclide, Manual
Cleared on Dec 30, 1994 after a 354-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Dec 30, 1994
- Review
- 354 days
- Class
- Class I
- Product code
- IWJ
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK940121 Implanters/Adjustable/Anderson's MarkersBest Industries · 1994
- Descendant · cites it directly · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- Descendant · 2 generations on · 11 of its ownK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- Descendant · 2 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- Descendant · 3 generations on · 4 of its ownK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · cites it directly20descendants
- K070305Pre-Loaded VisicoilRadiomed Corporation · 2007 · 2 generations on11descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 2 generations on9descendants
- K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · 3 generations on6descendants
- K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940121 | Implanters/Adjustable/Anderson's Markers | Best Industries | 1994 | — |
| +1 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| +2 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| +2 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| +3 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
| +3 | K112768 | Calypso Systems with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031206 | Radiomed Soft Tissue Marker | 2003 | 20 |
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, K031206 (Radiomed Corp., 2003) has gone furthest, with 20 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/K940121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940121: Implanters/Adjustable/Anderson's Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940121
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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