# K102683: The Addition

- Pathway: 510(k) (Traditional)
- Applicant: Ob The-Addition, LLC
- Decided: Jan 6, 2011 after 111 days
- Product code: MUI (Media, Coupling, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K802146 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031894: Scantec Pad, Sonotech, Inc. (2003) Summary page 1.
- K072515: Embrace Gel, Orison Corporation (2007) Summary page 1.

## Indications for use
The-Addition provides padding for patient comfort and aids in the retention of coupling media in a defined position.

Source page: https://510kreport.com/device/K102683
Methodology: https://510kreport.com/methodology