Inhal-O-Tech Medical Plastic: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Inhal-O-Tech Medical Plastic” (first 1976, latest 1978), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | 2 | 2 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 1 | 1 |
Review panels
- Anesthesiology (6)
- General Hospital (1)
Most recent Inhal-O-Tech Medical Plastic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K781741 | MASK, BI FLO NASAL OXYGEN | BYG | 1978-12-01 | 55 |
| K781394 | DISPOSABLE INCENTIVE SPIROMETER | CCQ | 1978-10-16 | 63 |
| K781395 | DISPOSABLE AEROSOL T BRIGGS ADAPTOR | BZA | 1978-08-31 | 17 |
| K770354 | TUBING, AEROSAL, DISPOSABLE | BZO | 1977-03-16 | 22 |
| K770353 | DISPOSABLE TEMPERATURE PROBE | KPD | 1977-03-16 | 22 |
| K760329 | MASK, DISPOSABLE OXYGEN THERAPY | BYG | 1976-09-30 | 64 |
| K760330 | CANNULA, DISPOSABLE OXYGEN TTHERAPY | CAT | 1976-08-04 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Inhal-O-Tech Medical Plastic.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Inhal-O-Tech Medical Plastic?
FDA lists 7 510(k) clearances under the applicant name “Inhal-O-Tech Medical Plastic” (first 1976, latest 1978), 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 Inhal-O-Tech Medical Plastic?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inhal-O-Tech Medical Plastic is 22 days.
Which FDA product codes appear under Inhal-O-Tech Medical Plastic?
The most frequent FDA product codes under this applicant name are BYG (Mask, Oxygen, 2); BZA (Connector, Airway (Extension), 1); BZO (Set, Tubing And Support, Ventilator (W Harness), 1).
Next steps
- See all 7 Inhal-O-Tech Medical Plastic clearances with predicates and recalls
- Run predicate analysis for product code BYG, Inhal-O-Tech Medical Plastic'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.