Cranial Technologies, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Cranial Technologies, Inc.” (first 2002, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 76 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cranial Technologies, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVA | Orthosis, Cranial | 2 | 1 |
| OAN | Orthosis, Cranial, Laser Scan | 2 | 2 |
Review panels
- Neurology (4)
Most recent Cranial Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K244056 | DOC Band 3D | OAN | 2025-03-17 | 76 |
| K042385 | DOC BAND-POSTOP | MVA | 2004-12-17 | 107 |
| K014012 | DOC BAND | OAN | 2002-01-28 | 54 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN980001 | De Novo | Orthosis, Cranial | 1998-05-29 |
Recalls
openFDA lists no recalls under a recalling firm named Cranial Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cranial Solutions (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cranial Technologies, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Cranial Technologies, Inc.” (first 2002, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cranial Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cranial Technologies, Inc. is 76 days.
Which FDA product codes appear under Cranial Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MVA (Orthosis, Cranial, 2); OAN (Orthosis, Cranial, Laser Scan, 2).
Next steps
- See all 3 Cranial Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MVA, Cranial Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.