# K012830: Lerman & Son Cranial Orthosis Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Lerman & Son
- Decided: Nov 20, 2001 after 89 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 K001167 (2000). 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)
- K001167: Opi Band, Orthomerica Products, Inc. (2000) Summary page 1.

## Indications for use
The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/deformational plagiocephaly).

Source page: https://510kreport.com/device/K012830
Methodology: https://510kreport.com/methodology