# K990990: Cet Prostate Applicator Set, Part Number 089.066

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Oct 7, 1999 after 197 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K953948: Spirovision SV-Iii PC Based Spirometer Kit Micro, Futuremed America, Inc. (1996). Our OCR of the scanned summary read K953948, FDA’s number for Spirovision SV-Iii PC Based Spirometer Kit Micro (Futuremed America, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Porter Perineal Applicator Set”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K082530: Applicators for Afterloading Brachytherapy (2008), 0 descendants of its own
- K031273: Ameritek Sure-Point HDR Needle Template (2003), 0 descendants of its own

## Indications for use
Nucletron CET Prostate Applicator Set is intended for use with Interstitial Prostate brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

Source page: https://510kreport.com/device/K990990
Methodology: https://510kreport.com/methodology