# K132124: Klarity Vacuum Bag, Klarity Mold Cushion

- Pathway: 510(k) (Traditional)
- Applicant: Klarity Medical Products, LLC
- Decided: Nov 1, 2013 after 114 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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: 2 generations back to K895697 (1990). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040773: Pelvis Bellyboard Plus Patient Positioning System, Bionix Development Corp. (2004) Summary page 1.
- K982624: Moldcare Head & Neck Cushion, Model # MT-Acl-14242, Med-Tec,Inc. (1998) Summary page 3.

## Most influential descendants
- K162265: CushionCast Moldable Cushions (2016), 0 descendants of its own

## Recalls of this device
- Jul 31, 2020 · Class II · Z-2881-2020: Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

## Indications for use
To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting. In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors. Patients are those that have been diagnosed and are undergoing treatment for cancerous tumors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

Source page: https://510kreport.com/device/K132124
Methodology: https://510kreport.com/methodology