Infrasonics Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Infrasonics Corp.” (first 1984, latest 1995), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 110 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 10 | 10 |
| BZC | Calculator, Pulmonary Function Data | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Anesthesiology (18)
- General Hospital (1)
- Neurology (1)
Most recent Infrasonics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943106 | ADULT VENTILATOR | CBK | 1995-12-28 | 547 |
| K952878 | OXY/STAR LOW FLOW BLENDER | BZR | 1995-09-25 | 94 |
| K934753 | STAR BREATHING CIRCUITS | BZO | 1993-10-27 | 23 |
| K922654 | VENTILATOR ADULT STAR MODIFICATION | CBK | 1992-12-01 | 181 |
| K923704 | INFANT STAR SERIES 500 | CBK | 1992-10-22 | 90 |
| K922477 | MODEL 105 VENTILATOR, MODIFICATION | CBK | 1992-08-24 | 89 |
| K920954 | AIR STAR | BTI | 1992-08-03 | 159 |
| K911804 | INFRASONICS VENTILATOR ADULT STAR, MODIFICATION | CBK | 1992-06-11 | 414 |
| K913972 | STAR SYNC, MODIFICATION | CBK | 1992-01-09 | 126 |
| K905272 | ADULT STAR, MODIFICATION | CBK | 1991-01-30 | 68 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Infrasonics Corp..
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 Infrasonics Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Infrasonics Corp.?
FDA lists 20 510(k) clearances under the applicant name “Infrasonics Corp.” (first 1984, latest 1995), across 9 product codes in 3 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 Infrasonics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infrasonics Corp. is 110 days.
Which FDA product codes appear under Infrasonics Corp.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 10); BZC (Calculator, Pulmonary Function Data, 2); BZO (Set, Tubing And Support, Ventilator (W Harness), 2).
Next steps
- See all 20 Infrasonics Corp. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Infrasonics Corp.'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.