Blue Ortho: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Blue Ortho” (first 2010, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 140 days. Since 2017 the median was 119 days, against 103 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 293 |
| 2017 | 2 | 116 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 251 |
| 2021 | 0 | — |
| 2022 | 2 | 100 |
| 2023 | 1 | 90 |
| 2024 | 1 | 119 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Blue Ortho took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 8 | 8 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (8)
- Neurology (1)
Most recent Blue Ortho 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233299 | ExactechGPS® System | OLO | 2024-01-26 | 119 |
| K232521 | ExactechGPS® Total Ankle Application | OLO | 2023-11-16 | 90 |
| K213877 | ExactechGPS® System | OLO | 2022-05-02 | 140 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | OLO | 2022-01-06 | 59 |
| K193618 | ExactechGPS System | OLO | 2020-09-02 | 251 |
| K173372 | ExactechGPS Total Shoulder Application | OLO | 2017-11-24 | 28 |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | OLO | 2017-04-05 | 203 |
| K152764 | EXACTECH GPS | HAW | 2016-07-13 | 293 |
| K100742 | EXACTECH GPS | OLO | 2010-10-21 | 219 |
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2024-08-30.
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.
- Blue Belt Technologies, Inc. (22 510(k)s)
- Blue Sky Bio, LLC (21 510(k)s)
- Blue Ridge Media Co. (11 510(k)s)
- Blue Sky Medical Group Incorporated (4 510(k)s)
- Blue Planet Industries, Inc. (3 510(k)s)
- Blue Sail Medical Co.,Ltd (2 510(k)s)
- Blue Spark Technologies, Inc. (2 510(k)s)
- Blue Torch Medical Technologies (2 510(k)s)
- Blue X Imaging Srl (2 510(k)s)
- Blue Cross Bio-Medical Co., Ltd. (1 510(k)s)
- Blue Dent Dental (1 510(k)s)
- Blue Egg CO (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Blue Ortho?
FDA lists 9 510(k) clearances under the applicant name “Blue Ortho” (first 2010, latest 2024), across 2 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 Blue Ortho?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blue Ortho is 140 days. Since 2017: 119 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Blue Ortho?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 8); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 9 Blue Ortho clearances with predicates and recalls
- Run predicate analysis for product code OLO, Blue Ortho'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.