# K961601: H.a.M. Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Dec 23, 1996 after 242 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.
28 later devices descend from it; 6 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061241: Biolucent Applicator, Model Rta-XX (2006), 17 descendants of its own
- K070659: Biolucent Applicator Kit (2007), 13 descendants of its own
- K080565: Modification to: Savi Applicator Kit (2008), 12 descendants of its own
- K081677: Savi Applicator Kit (2008), 11 descendants of its own
- K091378: Mammosite II Radiation Therapy System (2009), 9 descendants of its own

## Indications for use
The H.A.M. Applicator is intended to be used as an accessory to high-dose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.

Source page: https://510kreport.com/device/K961601
Methodology: https://510kreport.com/methodology