Ohio Medical Instrument Co., Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Ohio Medical Instrument Co., Inc.” (first 1983, latest 2002), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 7 | 7 |
| HAW | Neurological Stereotaxic Instrument | 4 | 4 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 2 |
| FRP | Holder, Infant Position | 1 | 1 |
| GDC | Table, Operating-Room, Electrical | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Plus 1 more product codes.
Review panels
- Neurology (13)
- General and Plastic Surgery (2)
- General Hospital (1)
- Orthopedic (1)
Most recent Ohio Medical Instrument Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021604 | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 | HBL | 2002-07-29 | 74 |
| K013428 | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM | HAW | 2002-04-04 | 170 |
| K992843 | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F | HAW | 1999-11-02 | 70 |
| K991267 | SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A | HAW | 1999-07-12 | 90 |
| K983282 | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 | KWP | 1998-11-19 | 62 |
| K982244 | MAYFIELD ACCISS OPTICAL SYSTEM | HAW | 1998-09-23 | 90 |
| K960807 | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 | GZT | 1996-05-17 | 79 |
| K953124 | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP | HBL | 1996-02-09 | 219 |
| K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN | HBL | 1995-12-06 | 615 |
| K934289 | MAYFIELD RADIOLUCENT SKULL CLAMP | HBL | 1994-01-07 | 127 |
9 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-02-26.
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.
- Ohio Medical Products (47 510(k)s)
- Ohio Nuclear, Inc. (7 510(k)s)
- Ohio Imaging, Inc. (3 510(k)s)
- Ohio Medical Corporation (2 510(k)s)
- Ohio Health Care Products, Inc. (1 510(k)s)
- Ohio Medical Research, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ohio Medical Instrument Co., Inc.?
FDA lists 19 510(k) clearances under the applicant name “Ohio Medical Instrument Co., Inc.” (first 1983, latest 2002), across 8 product codes in 4 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 Ohio Medical Instrument Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ohio Medical Instrument Co., Inc. is 90 days.
Which FDA product codes appear under Ohio Medical Instrument Co., Inc.?
The most frequent FDA product codes under this applicant name are HBL (Holder, Head, Neurosurgical (Skull Clamp), 7); HAW (Neurological Stereotaxic Instrument, 4); GZT (Retractor, Self-Retaining, For Neurosurgery, 2).
Next steps
- See all 19 Ohio Medical Instrument Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HBL, Ohio Medical Instrument Co., 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.