# K111555: Circumaural Adhesive Replacement

- Pathway: 510(k) (Traditional)
- Applicant: R & D Medical Products, Inc.
- Decided: Jul 25, 2011 after 52 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K936039 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013137: Algo 3 Newborn Hearing Screener, Natus Medical, Inc. (2001) Summary page 3.

## Indications for use
The Circumaural Adhesive Replacement is used to make earphones reusable for newborn hearing screening tests. It is a single use disposable to seal the earphones in place during the screening process. This skin adhesive is intended for use on the circumaural area of babies between the ages of 34 weeks (gestational age ) and 6 months. Sites appropriate for this screening test may include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Source page: https://510kreport.com/device/K111555
Methodology: https://510kreport.com/methodology