510(k) · Cleared

Cleared

Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis

K012804510(k) TraditionalCleared Jan 17, 2002149-day reviewClass II21 CFR 882.5970

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Scott E Allen CP · MVA Orthosis, Cranial

Cleared on Jan 17, 2002 as substantially equivalent to DEN980001 (Cranial Technologies, Inc., 1998) and 1 other predicate after a 149-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Jan 17, 2002
Review: 149 days
Class: Class II
Product code: MVA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to DEN980001 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
This deviceK012804 Plagiocephalic Applied Pressure Orthosis P.a.P. OrthosisScott E Allen CP · 2002
Descendant · cites it directly · 0 of its ownK041215 Cranial HelmetOtto Bock Healthcare LP · 2004

Most influential descendants

Showing 1 of 1 · See all

K041215Cranial HelmetOtto Bock Healthcare LP · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN980001	Dynamic Orthotic Cranioplasty Band; Doc Band	Cranial Technologies, Inc.	1998	—
0 (this device)	K012804	Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis	Scott E Allen CP	2002	—
+1	K041215	Cranial Helmet	Otto Bock Healthcare LP	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K012804, 1998–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MVA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MVA device

#1 K230444 Talee, Talee PostOpscore 11.8 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN980001	Dynamic Orthotic Cranioplasty Band; Doc Band 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.	Cranial Technologies, Inc.	1998	—
*	K001167	Opi Band Summary page 1 …s classified by the FDA as a cranial Orthosis #510 (k) K964992. And the STARband, manufactured by Orthomerica and is classified by the FDA as a cranial Orthosis #510 (k) k001167. It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to th…	Orthomerica Products, Inc.	2000	—

Also cleared against DEN980001: 8 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041215	Cranial Helmet	Otto Bock Healthcare LP	2004	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K041215 (Otto Bock Healthcare LP, 2004) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate DEN980001.

How does its category compare?

All MVA devices

MVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MVA

1in 2024

2007high 3 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVA

209in 2022

2007high 209 (2022) · low 104 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MVA

No recall names MVA since 2007.

Adverse event reports per year · MVA

1in 2022

2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code MVA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	0	—	1
2009	0	—	1
2010	1	—	2
2011	3	104	0
2012	0	—	0
2013	0	—	0
2014	3	114	0
2015	0	—	1
2016	0	—	1
2017	0	—	3
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	2	—	0
2022	3	209	1
2023	2	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012804: Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012804

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026