# K001544: Vaginal Applicator Shielded

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Nov 17, 2000 after 183 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K092534: Alatus Vaginal Balloon Packing System (2009), 1 descendant of its own
- K052351: HDR Iort Shielded Applicator (2005), 1 descendant of its own
- K120344: Radiapak Brachytherapy Applicator Balloon Device (2012), 0 descendants of its own
- K062135: Art Shielded Breast Applicator (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K001544
Methodology: https://510kreport.com/methodology