Cybermedic, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Cybermedic, Inc.” (first 1979, latest 1994), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | 3 | 3 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 2 | 2 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| JEH | Plethysmograph, Volume | 1 | 1 |
Review panels
- Anesthesiology (11)
Most recent Cybermedic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941813 | VENSHIELD | BYD | 1994-05-03 | 21 |
| K914205 | PFF-1 | BZG | 1992-05-01 | 225 |
| K903959 | NEONATAL METASCOPE | BZK | 1990-11-23 | 87 |
| K884910 | MODEL 1010, CY-MET | BZK | 1989-06-12 | 199 |
| K861418 | SPINNAKER | BZC | 1986-05-09 | 24 |
| K851197 | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | JEH | 1985-07-08 | 104 |
| K842782 | PHYSIOLOGICAL ANALYZER CM-710 | BZM | 1984-08-17 | 31 |
| K842760 | LUNG ANALYZER CM-310 | BZC | 1984-07-26 | 10 |
| K831586 | CM-VII PHYSIOLOGIC ANALYZER | BZM | 1984-03-19 | 307 |
| K800547 | MEDISTOR III LUNG ANALYZER | BZC | 1980-03-25 | 15 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cybermedic, Inc..
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 Cybermedic, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Cybermedic, Inc.” (first 1979, latest 1994), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cybermedic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cybermedic, Inc. is 31 days.
Which FDA product codes appear under Cybermedic, Inc.?
The most frequent FDA product codes under this applicant name are BZC (Calculator, Pulmonary Function Data, 3); BZK (Spirometer, Monitoring (W/Wo Alarm), 2); BZM (Calculator, Pulmonary Function Interpretor (Diagnostic), 2).
Next steps
- See all 11 Cybermedic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZC, Cybermedic, Inc.'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.