# K193383: SnugKap

- Pathway: 510(k) (Traditional)
- Applicant: Headstart, Ltd.
- Decided: Jun 7, 2021 after 550 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: 13 generations back to K001167 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180568: KidCap, Eastern Cranial Affiliates, LLC (2018) Summary page 4.
- K133397: P-POD, P-Pod (2014) Summary page 4.
- K180109: STARband, STARlight, St. Louis Band, Orthomerica Products, Inc. (2018) Summary page 4.
- K012920: Molded Cranial Helmet, Fairview Orthopedic Laboratory (2001) Summary page 4.

## Indications for use
The SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional Plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K193383
Methodology: https://510kreport.com/methodology