# K913908: Omnitron Gyn Applicator System

- Pathway: 510(k) (Traditional)
- Applicant: Omnitron Intl., Inc.
- Decided: Mar 6, 1992 after 189 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955844: Applicators for Varian Varisource Remote High Dose Rate Afterloader (1996), 4 descendants of its own
- K063381: CT Compatible F/S/D Applicators (2006), 1 descendant of its own
- K200221: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (2020), 0 descendants of its own
- K172675: Varian Cervical Sleeves (2018), 0 descendants of its own
- K033828: CT Compatible Intrauterine Sleeves, Cat #0311, 9406 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K913908
Methodology: https://510kreport.com/methodology