# K040704: Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Jun 18, 2004 after 92 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
Longest line of descent: 3 generations back to K912555 (1991). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871217: Henschke Afterloading Applicator, Mick Radio-Nuclear Instruments, Inc. (1987) Summary page 1.
- K891377: Hilaris-Nori Cervix Applicator, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.
- K033371: Varian Intracavitary Brachytherapy Applicators, Varian Medical Systems (2003) Summary page 1.

## Most influential descendants
- 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
- K141343: Axxent Cervical Applicator (2014), 0 descendants of its own

## Indications for use
The applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.

Source page: https://510kreport.com/device/K040704
Methodology: https://510kreport.com/methodology