510(k) · Cleared
ClearedWang Front Loading Applicator
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 Apr 14, 1989 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Apr 14, 1989
- Review
- 73 days
- Class
- Class I
- Product code
- IWJ
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK890485 Wang Front Loading ApplicatorMick Radio-Nuclear Instruments, Inc. · 1989
- Descendant · cites it directly · 18 of its ownK980601 Varisource Wright Vaginal Cuff Applicator for Varian Varisource…Varian Assoc., Inc. · 1998
- Descendant · 2 generations on · 17 of its ownK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- Descendant · 3 generations on · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K980601Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…Varian Assoc., Inc. · 1998 · cites it directly18descendants
- K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006 · 2 generations on17descendants
- K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · 2 generations on13descendants
- K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · 3 generations on12descendants
- K081677Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890485 | Wang Front Loading Applicator | Mick Radio-Nuclear Instruments, Inc. | 1989 | — |
| +1 | K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High… | Varian Assoc., Inc. | 1998 | — |
| +2 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| +2 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| +3 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +2 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate… | 1998 | 18 |
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, K980601 (Varian Assoc., Inc., 1998) has gone furthest, with 18 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/K890485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K890485: Wang Front Loading Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890485
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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