510(k) · Cleared
ClearedVarian Sterilization Boxes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 13, 2016 as substantially equivalent to K980576 (Varian Medical Systems, Inc., 1998) after a 99-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Apr 13, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871216 (1987). No later device cites it as a predicate yet.
- Root · 2 generations backK871216 Hilaris-Nori Endometrial ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
- 1 generation backK980576 Varian Endometrial Applicator for Varisource Remote High Dose Rate…Varian Medical Systems, Inc. · 1998
- This deviceK160021 Varian Sterilization BoxesVarian Medical Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980576 | Varian Endometrial Applicator for Varisource Remote High Dose Rate AfterloaderSummary page 4…21 CFR 892.5700, JAQ, Class II Common/Usual Name: Remote controlled radionuclide applicator system Predicate Devices: [K980576] VariSource Endometrial Applicator for VariSource Remote High Dose Rate Afterloader (predicate is… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 17.4 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K980576.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Varian Sterilization boxes are intended to securely store the applicator parts during steam sterilization process and
subsequent storage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160021: Varian Sterilization Boxes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026