# K935160: Minimuffs

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Feb 9, 1995 after 468 days
- Product code: EWE (Protector, Hearing (Circumaural))
- Device class: U
- 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 K781907 (1978). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781907: Ear Stopples for Noise Attention, Crown Delta Corp. (1978) Summary page 1.

## Indications for use
The Natus Medical Inc. MiniMuffsTM Neonatal Noise Attenuators are intended for use on newborns to provide reduction in the sound level reaching the newborn’s ear. Reducing noise can stabilize the heart rate, decrease adverse physiological states such as oxygen desaturation, can decrease behavior states such as crying and fussing, and can lead to an increase in length of sleep.

Source page: https://510kreport.com/device/K935160
Methodology: https://510kreport.com/methodology