# K052228: Smit Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corporation
- Decided: Nov 9, 2005 after 85 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: 2 generations back to K864210 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.

## Indications for use
The Smlt Sleeve is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment. The Smit Sleeve (189.660 to 189.667) is an accessory to the GYN Applicators and the Cf/MR Smit Sleeve (189.565) is an accessory to the CT/MR GYN Applicators.

Source page: https://510kreport.com/device/K052228
Methodology: https://510kreport.com/methodology