510(k) · Cleared

Cleared

Becker Band Cranial Remolding Orthosis

K013719510(k) TraditionalCleared Feb 5, 200289-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

Becker Orthopedic Appliance Co. · MVA Orthosis, Cranial

Cleared on Feb 5, 2002 as substantially equivalent to DEN980001 (Cranial Technologies, Inc., 1998) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1998.

Decided: Feb 5, 2002
Review: 89 days
Class: Class II
Product code: MVA
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to DEN980001 (1998). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
This deviceK013719 Becker Band Cranial Remolding OrthosisBecker Orthopedic Appliance Co. · 2002

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)	K013719	Becker Band Cranial Remolding Orthosis	Becker Orthopedic Appliance Co.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2001	1	0

FIG. 1 — Lineage of K013719, 1998–2002Source: 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
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What was it cleared against? (5)

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 …the classified device (Cranial Orthosis), to the Doc Band device of Cranial Teclinology, cleared under K-964992, the OPI Band cleared by Orthomerica Products, Inc. in K-001167, the Craniocap cleared by Gilette Childrens., in K-000861, and (he Cranial Molding Orthosis clearcd by Orthotic Solutions in K-01…	Orthomerica Products, Inc.	2000	—
*	K000861	Craniocap Summary page 1 …device of Cranial Teclinology, cleared under K-964992, the OPI Band cleared by Orthomerica Products, Inc. in K-001167, the Craniocap cleared by Gilette Childrens., in K-000861, and (he Cranial Molding Orthosis clearcd by Orthotic Solutions in K-010273. The devices are made of similar if not dentical matc…	Gillette Children'S Specialty Healthcare	2000	—
*	K010273	Cranial Molding Orthosis Summary page 1 …by Orthomerica Products, Inc. in K-001167, the Craniocap cleared by Gilette Childrens., in K-000861, and (he Cranial Molding Orthosis clearcd by Orthotic Solutions in K-010273. The devices are made of similar if not dentical matcrials widely used in the orthotic industry, by well-known technology, under…	Orthotic Solutions, Inc.	2001	—
*	—	Cranial Orthosis Named without a submission number			—

Also cleared against DEN980001: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 4 ancestors has a recall.
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?

Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with

moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Contraindications for use: Infants with synostosis or hydrocephalus.

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/K013719 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013719: Becker Band Cranial Remolding Orthosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013719

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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