Inhalation Plastics: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Inhalation Plastics” (first 1988, latest 1995), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (5)
- General Hospital (2)
Most recent Inhalation Plastics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945565 | SPIRO-FLEX | CAI | 1995-01-13 | 119 |
| K914686 | THERMO-FLOW SET | BTT | 1992-04-15 | 180 |
| K901315 | AEROMIST II NEBULIZER | CAF | 1990-09-10 | 173 |
| K900990 | FILT-R-ALL BACTERIAL/VIRAL FILTER | CAH | 1990-04-19 | 48 |
| K900594 | ANESTHESIA BREATHING CIRCUIT | CAI | 1990-03-15 | 36 |
| K896832 | FILT-R-ALL BACTERIAL FILTER | CAH | 1990-01-22 | 48 |
| K874659 | STERILIZATION OF DEVICES BY RADIATION | BTT | 1988-02-02 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Inhalation Plastics.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Inhalation Plastics (a text match, not an official crosswalk):
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.
- Inhalation Therapy Equipment, Co. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inhalation Plastics?
FDA lists 7 510(k) clearances under the applicant name “Inhalation Plastics” (first 1988, latest 1995), across 4 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 Inhalation Plastics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inhalation Plastics is 105 days.
Which FDA product codes appear under Inhalation Plastics?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2); CAH (Filter, Bacterial, Breathing-Circuit, 2); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 2).
Next steps
- See all 7 Inhalation Plastics clearances with predicates and recalls
- Run predicate analysis for product code BTT, Inhalation Plastics'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.