# K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Apr 3, 2003 after 80 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864210 (1986). 4 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011657: HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2001)

## Most influential descendants
- K150839: 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 (2015), 2 descendants of its own
- K122840: CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407 (2012), 2 descendants of its own
- K063382: HDR CT Compatible Split Ring Applicator (2006), 2 descendants of its own
- K222775: Aarhus Applicator Set (2023), 1 descendant of its own
- K063381: CT Compatible F/S/D Applicators (2006), 1 descendant of its own

## Recalls of this device
- Mar 12, 2008 · Not classified · Z-2081-2008: Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.

## Indications for use
The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

Source page: https://510kreport.com/device/K030110
Methodology: https://510kreport.com/methodology