510(k) · Cleared
ClearedOmnitron Gyn Applicator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnitron Intl., Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Mar 6, 1992 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 6, 1992
- Review
- 189 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK913908 Omnitron Gyn Applicator SystemOmnitron Intl., Inc. · 1992
- Descendant · cites it directly · 4 of its ownK955844 Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 1996
- Descendant · cites it directly · 1 of its ownK063381 CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006
- Descendant · 2 generations on · 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 ownK172675 Varian Cervical SleevesVarian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK033828 CT Compatible Intrauterine Sleeves, Cat #0311, 9406Mick Radio-Nuclear Instruments, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 1996 · cites it directly4descendants
- K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006 · cites it directly1descendant
- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · 2 generations on0descendants
- K172675Varian Cervical SleevesVarian Medical Systems, Inc. · 2018 · 2 generations on0descendants
- K033828CT Compatible Intrauterine Sleeves, Cat #0311, 9406Mick Radio-Nuclear Instruments, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913908 | Omnitron Gyn Applicator System | Omnitron Intl., Inc. | 1992 | — |
| +1 | K955844 | Applicators for Varian Varisource Remote High Dose Rate Afterloader | Varian Assoc., Inc. | 1996 | — |
| +1 | K063381 | CT Compatible F/S/D Applicators | Mick Radio-Nuclear Instruments, Inc. | 2006 | — |
| +2 | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid… | Mick Radio-Nuclear Instruments, Inc. | 2020 | — |
| +2 | K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | 2018 | — |
| +2 | K033828 | CT Compatible Intrauterine Sleeves, Cat #0311, 9406 | Mick Radio-Nuclear Instruments, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 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, K955844 (Varian Assoc., Inc., 1996) has gone furthest, with 4 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K913908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913908: Omnitron Gyn Applicator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913908
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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