# K092781: Mam Twister

- Pathway: 510(k) (Traditional)
- Applicant: Mam International AG
- Decided: Jun 23, 2010 after 286 days
- Product code: KKO (Ring, Teething, Fluid-Filled)
- Device class: 2
- Regulation: 21 CFR 872.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052105 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K052105: Water Filled Teether, Royal Industries (Thailand) Public Co., Ltd. (2005) Summary page 2.

## Most influential descendants
- K123855: Water-Filled Teether (2013), 0 descendants of its own

## Indications for use
The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It ik designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.

Source page: https://510kreport.com/device/K092781
Methodology: https://510kreport.com/methodology