Mighty Oak Medical: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Mighty Oak Medical” (first 2015, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 145 days. Since 2017 the median was 145 days, against 131 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 396 |
| 2016 | 1 | 59 |
| 2017 | 0 | — |
| 2018 | 2 | 69 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 281 |
| 2023 | 0 | — |
| 2024 | 1 | 206 |
| 2025 | 2 | 160 |
| 2026 | 2 | 135 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mighty Oak Medical took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQC | Pedicle Screw Placement Guide | 4 | 4 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| QSD | Posterior Cervical Screw Placement Guide | 1 | 1 |
Review panels
- Orthopedic (6)
- Radiology (4)
Most recent Mighty Oak Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | QIH | 2026-06-11 | 132 |
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | PQC | 2026-02-25 | 138 |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | QIH | 2025-12-02 | 152 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | LLZ | 2025-11-03 | 168 |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | QIH | 2024-07-12 | 206 |
| K220132 | FIREFLY® Cervical Navigation Guide | QSD | 2022-10-26 | 281 |
| K181883 | FIREFLY® Midline Navigation Guide | PQC | 2018-10-03 | 82 |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | PQC | 2018-07-24 | 56 |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | PQC | 2016-10-28 | 59 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | MNI | 2015-12-11 | 396 |
Recalls
openFDA lists no recalls under a recalling firm named Mighty Oak Medical.
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.
- Mighty Mo, Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mighty Oak Medical?
FDA lists 10 510(k) clearances under the applicant name “Mighty Oak Medical” (first 2015, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mighty Oak Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mighty Oak Medical is 145 days. Since 2017: 145 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mighty Oak Medical?
The most frequent FDA product codes under this applicant name are PQC (Pedicle Screw Placement Guide, 4); QIH (Automated Radiological Image Processing Software, 3); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 10 Mighty Oak Medical clearances with predicates and recalls
- Run predicate analysis for product code PQC, Mighty Oak Medical'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.