Intertech/Ohio: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Intertech/Ohio” (first 1986, latest 1989), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
Review panels
- Anesthesiology (9)
- General Hospital (1)
Most recent Intertech/Ohio 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895144 | INTERTECH METERED DOSE ELBOW | BZA | 1989-10-19 | 62 |
| K890346 | INTERTECH UNIVERSAL HYDROPHOBIC FILTER | CAH | 1989-03-01 | 37 |
| K884525 | PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT | BZO | 1988-12-16 | 50 |
| K884526 | ADULT RESUSCITATOR WITH MASK AND FILTER | BTM | 1988-11-16 | 20 |
| K882204 | RESUSCITATOR VALVE ASSEMBLY W/FILTER | CBP | 1988-07-08 | 44 |
| K880394 | FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR | BTM | 1988-02-29 | 31 |
| K863033 | PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS | BZO | 1986-08-20 | 9 |
| K862020 | HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER | BYD | 1986-06-30 | 33 |
| K860650 | 90 DEGREE ELBOW & STRAIGHT CONNECTOR | BZA | 1986-03-28 | 35 |
| K861056 | STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG | BZA | 1986-03-27 | 8 |
Recalls
openFDA lists no recalls under a recalling firm named Intertech/Ohio.
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.
- Intertech Resources, Inc. (29 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intertech/Ohio?
FDA lists 10 510(k) clearances under the applicant name “Intertech/Ohio” (first 1986, latest 1989), across 6 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 Intertech/Ohio?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intertech/Ohio is 34 days.
Which FDA product codes appear under Intertech/Ohio?
The most frequent FDA product codes under this applicant name are BZA (Connector, Airway (Extension), 3); BTM (Ventilator, Emergency, Manual (Resuscitator), 2); BZO (Set, Tubing And Support, Ventilator (W Harness), 2).
Next steps
- See all 10 Intertech/Ohio clearances with predicates and recalls
- Run predicate analysis for product code BZA, Intertech/Ohio'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.