Cavitron Corp.: FDA clearances and approvals
Cavitron Corp. has 32 FDA 510(k) clearances (first 1976, latest 1981), across 24 product codes in 9 review panels. Median 510(k) review time: 30 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| EHL | Point, Abrasive | 3 | 3 |
| BZC | Calculator, Pulmonary Function Data | 2 | 2 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| HPT | Perimeter, Automatic, Ac-Powered | 2 | 2 |
| HQB | Photocoagulator And Accessories | 2 | 2 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Plus 14 more product codes.
Review panels
- Anesthesiology (7)
- Dental (7)
- Ophthalmic (6)
- General and Plastic Surgery (4)
- General Hospital (3)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent Cavitron Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811582 | THE PLACER | EID | 1981-07-28 | 53 |
| K810207 | MINOR SURGERY LIGHT | GBC | 1981-02-13 | 18 |
| K802928 | SPIROMETRIC COMPUTER #SC-10 | BZC | 1980-12-17 | 28 |
| K801623 | CAVITRON ULTRASONIC SURG. ASPIR. CUSA | LFL | 1980-11-18 | 126 |
| K801877 | SLIT LAMP ATTACHMENT | HQB | 1980-09-16 | 41 |
| K800869 | MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA | CCK | 1980-05-28 | 41 |
| K800722 | AUTO-FIELD D AUTOMATED VISUAL DETECTOR | HPT | 1980-04-29 | 28 |
| K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | ELC | 1979-09-19 | 33 |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | HDQ | 1979-08-22 | 43 |
| K782054 | LASER, CO2 SURGICAL | HHR | 1979-01-17 | 41 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cavitron Corp..
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 Cavitron Corp. have?
Cavitron Corp. has 32 FDA 510(k) clearances (first 1976, latest 1981), across 24 product codes in 9 review panels.
How long does FDA take to clear Cavitron Corp.'s 510(k)s?
The median time from FDA receipt to decision across Cavitron Corp.'s cleared 510(k)s is 30 days.
What devices does Cavitron Corp. make?
Its most frequent FDA product codes are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 3); EHL (Point, Abrasive, 3); BZC (Calculator, Pulmonary Function Data, 2).
Has Cavitron Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cavitron Corp. Related entities may recall under other names.
Next steps
- See all 32 Cavitron Corp. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Cavitron Corp.'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.