Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MVA — Predicate Candidate Screening

43 FDA 510(k) clearances under this product code; the 50 most recent screened below.

121 daysmedian FDA review time

330 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days
K241957	Talee, Talee PostOp	Invent Medical USA, LLC	2024-08-30	58
K230444	Talee, Talee PostOp	Invent Medical USA, LLC	2023-06-22	121
K223238	STARband 3D	Orthomerica Products, Inc.	2023-04-20	182
K220681	Talee, Talee PostOP	Invent Medical USA, LLC	2022-09-22	198
K203134	Hanger Cranial Band 3D	Symbion Logistics, LLC	2022-07-01	620
K213587	MyCRO Band	Otto Bock Healthcare LP	2022-06-09	209
K193383	SnugKap	Headstart, Ltd.	2021-06-07	550
K201426	MyCRO Band	Otto Bock Healthcare LP	2021-03-26	301
K180568	KidCap	Eastern Cranial Affiliates, LLC	2018-10-16	225
K141842	STARBAND, STARLIGHT	Orthomerica Products, Inc.	2014-10-06	90
K140353	STARBAND AND STARLIGHT	Orthomerica Products, Inc.	2014-06-06	114
K133397	P-POD	P-Pod	2014-04-18	163
K111609	BOSTON BAND	Boston Brace Intl., Inc.	2011-08-22	74
K111247	CRANIAL REMOLDING ORTHOSIS	Orthotic Care Services, Llp	2011-08-15	104
K103362	AOI CRANIAL HELMET	Advanced Orthopro, Inc.	2011-04-18	152
K090341	MICHIGAN CRANIAL RESHAPING ORTHOSIS	Danmar Products, Inc.	2010-01-06	330
K070694	CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)	Mike Miner	2007-09-10	181
K063133	CRANIAL SOLUTION ORTHOSIS	Cranial Solutions	2007-07-02	262
K063395	O&P BIVALVE CRANIAL MOLDING HELMET	Orthotic & Prosthetic Lab, Inc.	2006-12-22	43
K042385	DOC BAND-POSTOP	Cranial Technologies, Inc.	2004-12-17	107
K041215	CRANIAL HELMET	Otto Bock Healthcare LP	2004-09-09	122
K021594	COPC BAND	Center For Orthotic and Prosthetic Care,Llc	2003-11-13	547
K013452	DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS	Danmar Products, Inc.	2003-10-31	743
K030669	PROVIDENCE MOLDING HELMET	Northeast Orthotics and Prothetics, Inc.	2003-07-18	137
K023572	LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDI	Rehabilitation Institute,Loma Linda University Med	2003-01-13	81
K022273	CRANIAL SYMMETRY SYSTEM	Beverly Hills Prosthetics Orthotics, Inc.	2002-09-09	56
K021221	O&P CRANICAL MOLDING HELMET	Orthotic & Prosthetic Lab, Inc.	2002-07-01	75
K020448	STATIC CRANIOPLASTY ORTHOSIS	Eastern Cranial Affiliates	2002-04-12	60
K013719	BECKER BAND CRANIAL REMOLDING ORTHOSIS	Becker Orthopedic Appliance Co.	2002-02-05	89
K013700	ORTHOSIS HELMET MOLDING	Precision Prosthetics & Orthotics, Inc.	2002-02-05	89
K012804	PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS	Scott E Allen CP	2002-01-17	149
K012920	MOLDED CRANIAL HELMET	Fairview Orthopedic Laboratory	2001-11-28	90
K012830	LERMAN & SON CRANIAL ORTHOSIS HELMET	Lerman & Son	2001-11-20	89
K013458	CRANIAL HELMET	Children'S Hospital	2001-10-29	11
K012007	RHS HELMET	Restorative Health Svs, Inc.	2001-09-19	84
K011433	BALLERT CRANIAL MOLDING HELMET	Gema, Inc.	2001-06-12	33
K003035	CLARREN HELMET	Children'S Hospital & Medical Center	2001-06-06	251
K003630	DANMAR PRODUCTS MICHIGAN CRANIAL HELMET	Danmar Products, Inc.	2001-05-29	186
K010273	CRANIAL MOLDING ORTHOSIS	Orthotic Solutions, Inc.	2001-04-25	86
K001669	HANGER CRANIAL BAND	Hanger Orthopedic Group, Inc.	2000-12-08	191
K000861	CRANIOCAP	Gillette Children'S Specialty Healthcare	2000-10-30	227
K001167	OPI BAND	Orthomerica Products, Inc.	2000-07-07	88
DEN980001	DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND	Cranial Technologies, Inc.	1998-05-29	59

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda