Sontek Industries, Inc.: FDA clearances and approvals
Sontek Industries, Inc. has 7 FDA 510(k) clearances (first 1981, latest 1983), across 4 product codes in 2 review panels. Median 510(k) review time: 37 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| JAY | Support, Breathing Tube | 2 | 2 |
| ILQ | System, Communication, Powered | 1 | 1 |
Review panels
- Anesthesiology (6)
- Physical Medicine (1)
Most recent Sontek Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833374 | BITE-BLOCK | JAY | 1983-11-03 | 37 |
| K833373 | BODIA BRONCH-SAF DOUBLE SWIVEL | BZA | 1983-11-03 | 37 |
| K833372 | BODIA TRACH-SAF DOUBLE SWIVEL | BZA | 1983-11-03 | 37 |
| K833361 | TUBE-TITLE | JAY | 1983-11-03 | 37 |
| K813324 | BODAI SWIVEL Y | BSY | 1981-12-29 | 35 |
| K812720 | BODAI PATIENT COMMUNICATOR | ILQ | 1981-11-05 | 41 |
| K811241 | BODAI SUCTION -SAFE 4 | BSY | 1981-05-27 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Sontek Industries, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Sontek Industries, Inc. have?
Sontek Industries, Inc. has 7 FDA 510(k) clearances (first 1981, latest 1983), across 4 product codes in 2 review panels.
How long does FDA take to clear Sontek Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sontek Industries, Inc.'s cleared 510(k)s is 37 days.
What devices does Sontek Industries, Inc. make?
Its most frequent FDA product codes are BSY (Catheters, Suction, Tracheobronchial, 2); BZA (Connector, Airway (Extension), 2); JAY (Support, Breathing Tube, 2).
Has Sontek Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sontek Industries, Inc. Related entities may recall under other names.
Next steps
- See all 7 Sontek Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSY, Sontek Industries, Inc.'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.