510(k) · Cleared

Cleared

Opi Band

K001167510(k) TraditionalCleared Jul 7, 200088-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

Orthomerica Products, Inc. · MVA Orthosis, Cranial

Cleared on Jul 7, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.

Decided: Jul 7, 2000
Review: 88 days
Class: Class II
Product code: MVA
Recalls: None
Predicates: 0

31 later devices descend from it, 5 citing it directly.

This deviceK001167 Opi BandOrthomerica Products, Inc. · 2000
Descendant · cites it directly · 25 of its ownK021207 StarlightOrthomerica Products, Inc. · 2002
Descendant · 2 generations on · 24 of its ownK081994 StarlightOrthomerica Products, Inc. · 2008
Descendant · 3 generations on · 21 of its ownK082950 StarbandOrthomerica Products, Inc. · 2008
Descendant · 4 generations on · 16 of its ownK111609 Boston BandBoston Brace Intl., Inc. · 2011
Descendant · 3 generations on · 16 of its ownK082945 StarlightOrthomerica Products, Inc. · 2008

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2001high 4 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 31 · See all

K021207StarlightOrthomerica Products, Inc. · 2002 · cites it directly25descendants
K081994StarlightOrthomerica Products, Inc. · 2008 · 2 generations on24descendants
K082950StarbandOrthomerica Products, Inc. · 2008 · 3 generations on21descendants
K111609Boston BandBoston Brace Intl., Inc. · 2011 · 4 generations on16descendants
K082945StarlightOrthomerica Products, Inc. · 2008 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001167	Opi Band	Orthomerica Products, Inc.	2000	—
+1	K021207	Starlight	Orthomerica Products, Inc.	2002	—
+2	K081994	Starlight	Orthomerica Products, Inc.	2008	—
+3	K082950	Starband	Orthomerica Products, Inc.	2008	—
+4	K111609	Boston Band	Boston Brace Intl., Inc.	2011	—
+3	K082945	Starlight	Orthomerica Products, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	3	0
2004	1	0
2008	3	0
2009	1	0
2011	3	0
2013	1	0
2014	3	0
2015	3	0
2016	1	0
2018	1	0
2021	4	0
2022	2	0
2023	2	0
2024	2	0

FIG. 1 — Lineage of K001167, 2000–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021207	Starlight	Orthomerica Products, Inc.	2002	25
K012804	Plagiocephalic Applied Pressure Orthosis P.a.P. Orthosis	Scott E Allen CP	2002	1
K103362	Aoi Cranial Helmet	Advanced Orthopro, Inc.	2011	0
K013719	Becker Band Cranial Remolding Orthosis	Becker Orthopedic Appliance Co.	2002	0
K012830	Lerman & Son Cranial Orthosis Helmet	Lerman & Son	2001	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?

Of its descendants, K021207 (Orthomerica Products, Inc., 2002) has gone furthest, with 25 descendants of its own.

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	—	—

https://510kreport.com/device/K001167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001167: Opi Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001167

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026