# K871216: Hilaris-Nori Endometrial Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Jul 21, 1987 after 117 days
- Product code: IWJ (System, Applicator, Radionuclide, Manual)
- Device class: 1
- Regulation: 21 CFR 892.5650
- 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; 3 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980576: Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader (1998), 2 descendants of its own
- K993472: Segmented Vaginal Applicator (2000), 1 descendant of its own
- K232623: Universal Endometrial Applicator Set (GM11009840) (2024), 0 descendants 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
- K160021: Varian Sterilization Boxes (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K871216
Methodology: https://510kreport.com/methodology