Ortho Instruments: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ortho Instruments” (first 1978, latest 1980), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 3 | 3 |
| JPK | Mixture, Hematology Quality Control | 3 | 3 |
Review panels
- Hematology (6)
Most recent Ortho Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K803084 | ORTHO HEMATOLOGY CONTROL ABNORMAL LOW | JPK | 1980-12-31 | 26 |
| K803083 | ORTHO HEMOTOLOGY CONTROL-NORMAL | JPK | 1980-12-31 | 26 |
| K803073 | ORTHO HEMATOLOGY CONTROL | JPK | 1980-12-31 | 26 |
| K802094 | ORTHO SPECTRUM | GKL | 1980-10-10 | 38 |
| K801545 | ORTHO AUTOMATED CELL COUNTER | GKL | 1980-09-09 | 64 |
| K781146 | HEMAC LASER HEMATOLOGY SYSTEM | GKL | 1978-09-14 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Ortho Instruments.
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.
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Clinical Diagnostics (16 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Pared Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Instruments?
FDA lists 6 510(k) clearances under the applicant name “Ortho Instruments” (first 1978, latest 1980), 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 Ortho Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Instruments is 32 days.
Which FDA product codes appear under Ortho Instruments?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 3); JPK (Mixture, Hematology Quality Control, 3).
Next steps
- See all 6 Ortho Instruments clearances with predicates and recalls
- Run predicate analysis for product code GKL, Ortho Instruments'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.