510(k) · Cleared
ClearedHilaris-Nori Endometrial 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 Jul 21, 1987 after a 117-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
- Jul 21, 1987
- Review
- 117 days
- Class
- Class I
- Product code
- IWJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK871216 Hilaris-Nori Endometrial ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
- Descendant · cites it directly · 2 of its ownK980576 Varian Endometrial Applicator for Varisource Remote High Dose Rate…Varian Medical Systems, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK993472 Segmented Vaginal ApplicatorMick Radio-Nuclear Instruments, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK232623 Universal Endometrial Applicator Set (GM11009840)Varian Medical Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK160021 Varian Sterilization BoxesVarian Medical Systems, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K980576Varian Endometrial Applicator for Varisource Remote High Dose Rate AfterloaderVarian Medical Systems, Inc. · 1998 · cites it directly2descendants
- K993472Segmented Vaginal ApplicatorMick Radio-Nuclear Instruments, Inc. · 2000 · cites it directly1descendant
- K232623Universal Endometrial Applicator Set (GM11009840)Varian Medical Systems, Inc. · 2024 · 2 generations on0descendants
- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · cites it directly0descendants
- K160021Varian Sterilization BoxesVarian Medical Systems, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871216 | Hilaris-Nori Endometrial Applicator | Mick Radio-Nuclear Instruments, Inc. | 1987 | — |
| +1 | K980576 | Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader | Varian Medical Systems, Inc. | 1998 | — |
| +1 | K993472 | Segmented Vaginal Applicator | Mick Radio-Nuclear Instruments, Inc. | 2000 | — |
| +2 | K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | 2024 | — |
| +1 | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid… | Mick Radio-Nuclear Instruments, Inc. | 2020 | — |
| +2 | K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (5)
3 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, K980576 (Varian Medical Systems, Inc., 1998) has gone furthest, with 2 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/K871216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K871216: Hilaris-Nori Endometrial Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871216
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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