# K012804: Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis

- Pathway: 510(k) (Traditional)
- Applicant: Scott E Allen CP
- Decided: Jan 17, 2002 after 149 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 DEN980001 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN980001: Dynamic Orthotic Cranioplasty Band; Doc Band, Cranial Technologies, Inc. (1998). Our OCR of the scanned summary read K964992, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980001, Dynamic Orthotic Cranioplasty Band; Doc Band (Cranial Technologies, Inc.), granted May 29, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K001167: Opi Band, Orthomerica Products, Inc. (2000) Summary page 1.

## Most influential descendants
- K041215: Cranial Helmet (2004), 0 descendants of its own

## Indications for use
The indications for use would include infants from three to eighteen months of age to be diagnosed with Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. This P.A.P. therapy must be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.

Source page: https://510kreport.com/device/K012804
Methodology: https://510kreport.com/methodology