MVA
43 FDA 510(k) clearances · Product code
121 daysmedian time to decision
330 days90th percentile
43clearances measured
FDA profile
- Official device name
- Orthosis, Cranial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5970
- Medical specialty
- Neurology
- Adverse events (MAUDE)
- 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Talee, Talee PostOp (K241957) | Invent Medical USA, LLC | 2024-08-30 |
| Talee, Talee PostOp (K230444) | Invent Medical USA, LLC | 2023-06-22 |
| STARband 3D (K223238) | Orthomerica Products, Inc. | 2023-04-20 |
| Talee, Talee PostOP (K220681) | Invent Medical USA, LLC | 2022-09-22 |
| Hanger Cranial Band 3D (K203134) | Symbion Logistics, LLC | 2022-07-01 |
| MyCRO Band (K213587) | Otto Bock Healthcare LP | 2022-06-09 |
| SnugKap (K193383) | Headstart, Ltd. | 2021-06-07 |
| MyCRO Band (K201426) | Otto Bock Healthcare LP | 2021-03-26 |
| KidCap (K180568) | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| STARBAND, STARLIGHT (K141842) | Orthomerica Products, Inc. | 2014-10-06 |
| STARBAND AND STARLIGHT (K140353) | Orthomerica Products, Inc. | 2014-06-06 |
| P-POD (K133397) | P-Pod | 2014-04-18 |
| BOSTON BAND (K111609) | Boston Brace Intl., Inc. | 2011-08-22 |
| CRANIAL REMOLDING ORTHOSIS (K111247) | Orthotic Care Services, Llp | 2011-08-15 |
| AOI CRANIAL HELMET (K103362) | Advanced Orthopro, Inc. | 2011-04-18 |
| MICHIGAN CRANIAL RESHAPING ORTHOSIS (K090341) | Danmar Products, Inc. | 2010-01-06 |
| CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) (K070694) | Mike Miner | 2007-09-10 |
| CRANIAL SOLUTION ORTHOSIS (K063133) | Cranial Solutions | 2007-07-02 |
| O&P BIVALVE CRANIAL MOLDING HELMET (K063395) | Orthotic & Prosthetic Lab, Inc. | 2006-12-22 |
| DOC BAND-POSTOP (K042385) | Cranial Technologies, Inc. | 2004-12-17 |
| CRANIAL HELMET (K041215) | Otto Bock Healthcare LP | 2004-09-09 |
| COPC BAND (K021594) | Center For Orthotic and Prosthetic Care,Llc | 2003-11-13 |
| DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS (K013452) | Danmar Products, Inc. | 2003-10-31 |
| PROVIDENCE MOLDING HELMET (K030669) | Northeast Orthotics and Prothetics, Inc. | 2003-07-18 |
| LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET (K023572) | Rehabilitation Institute,Loma Linda University Med | 2003-01-13 |
| CRANIAL SYMMETRY SYSTEM (K022273) | Beverly Hills Prosthetics Orthotics, Inc. | 2002-09-09 |
| O&P CRANICAL MOLDING HELMET (K021221) | Orthotic & Prosthetic Lab, Inc. | 2002-07-01 |
| STATIC CRANIOPLASTY ORTHOSIS (K020448) | Eastern Cranial Affiliates | 2002-04-12 |
| BECKER BAND CRANIAL REMOLDING ORTHOSIS (K013719) | Becker Orthopedic Appliance Co. | 2002-02-05 |
| ORTHOSIS HELMET MOLDING (K013700) | Precision Prosthetics & Orthotics, Inc. | 2002-02-05 |
| PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS (K012804) | Scott E Allen CP | 2002-01-17 |
| MOLDED CRANIAL HELMET (K012920) | Fairview Orthopedic Laboratory | 2001-11-28 |
| LERMAN & SON CRANIAL ORTHOSIS HELMET (K012830) | Lerman & Son | 2001-11-20 |
| CRANIAL HELMET (K013458) | Children'S Hospital | 2001-10-29 |
| RHS HELMET (K012007) | Restorative Health Svs, Inc. | 2001-09-19 |
| BALLERT CRANIAL MOLDING HELMET (K011433) | Gema, Inc. | 2001-06-12 |
| CLARREN HELMET (K003035) | Children'S Hospital & Medical Center | 2001-06-06 |
| DANMAR PRODUCTS MICHIGAN CRANIAL HELMET (K003630) | Danmar Products, Inc. | 2001-05-29 |
| CRANIAL MOLDING ORTHOSIS (K010273) | Orthotic Solutions, Inc. | 2001-04-25 |
| HANGER CRANIAL BAND (K001669) | Hanger Orthopedic Group, Inc. | 2000-12-08 |
| CRANIOCAP (K000861) | Gillette Children'S Specialty Healthcare | 2000-10-30 |
| OPI BAND (K001167) | Orthomerica Products, Inc. | 2000-07-07 |
| DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND (DEN980001) | Cranial Technologies, Inc. | 1998-05-29 |
Track MVA automatically
Every clearance here is in the API, with alerts when new ones post.