# K030669: Providence Molding Helmet

- Pathway: 510(k) (Abbreviated)
- Applicant: Northeast Orthotics and Prothetics, Inc.
- Decided: Jul 18, 2003 after 137 days
- Product code: MVA (Orthosis, Cranial)
- Device class: 2
- Regulation: 21 CFR 882.5970
- 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 K011433 (2001). 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)
- K011433: Ballert Cranial Molding Helmet, Gema, Inc. (2001) Summary page 1.

## Most influential descendants
- K070694: Ccro (Craniocephalic Custom Remolding Orthosis) (2007), 0 descendants of its own

## Indications for use
The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry andor shape.

Source page: https://510kreport.com/device/K030669
Methodology: https://510kreport.com/methodology