Ohio Medical Products: FDA clearances and approvals
Ohio Medical Products has 47 FDA 510(k) clearances (first 1976, latest 1984), across 30 product codes in 4 review panels. Median 510(k) review time: 26 days.
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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 5 | 5 |
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 3 | 3 |
| FMT | Warmer, Infant Radiant | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 2 | 2 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| CBN | Apparatus, Gas-Scavenging | 2 | 2 |
| FMZ | Incubator, Neonatal | 2 | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 2 |
Plus 20 more product codes.
Review panels
- Anesthesiology (30)
- General Hospital (13)
- Cardiovascular (2)
- Dental (1)
Most recent Ohio Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841733 | OHIO WASTE GAS SCAVENGING RESERVOIR | CBN | 1984-07-11 | 76 |
| K842003 | OHIO WASTE GAS SCAVENGING INTERFACE | CBN | 1984-05-23 | 7 |
| K840356 | OHIO UNITROL II ANESTHESIA GAS MACHINE | BSZ | 1984-04-20 | 85 |
| K841274 | BAG-TO-VENTILATOR SELECTOR VALVE | BSZ | 1984-04-13 | 17 |
| K840967 | OHIO HEAT REFLECTING PATCH | FMI | 1984-03-23 | 17 |
| K840858 | OHIO 3300 INFANT WARMER SYSTEM | FMT | 1984-03-23 | 28 |
| K840857 | OHIO 3000 INFANT WARMER SYSTEM | FMT | 1984-03-23 | 28 |
| K840453 | MEDISHIELD PVM RESPIROMETER | BZK | 1984-03-02 | 30 |
| K840452 | PREMIUM DABM DISPOS. ANES. BREATH MASK | BSJ | 1984-02-17 | 16 |
| K833335 | MODULUS II ANESTHESIA GAS MACHINE | BSZ | 1983-11-14 | 48 |
37 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ohio Medical Products.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Ohio Medical Products's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Ohio Medical Products have?
Ohio Medical Products has 47 FDA 510(k) clearances (first 1976, latest 1984), across 30 product codes in 4 review panels.
How long does FDA take to clear Ohio Medical Products's 510(k)s?
The median time from FDA receipt to decision across Ohio Medical Products's cleared 510(k)s is 26 days.
What devices does Ohio Medical Products make?
Its most frequent FDA product codes are BSZ (Gas-Machine, Anesthesia, 5); CBK (Ventilator, Continuous, Facility Use, 4); BZK (Spirometer, Monitoring (W/Wo Alarm), 3).
Has Ohio Medical Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Ohio Medical Products. Related entities may recall under other names.
Next steps
- See all 47 Ohio Medical Products clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Ohio Medical Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.