Caradyne, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Caradyne, Ltd.” (first 1999, latest 2004), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 156 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Caradyne, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM | BZD | 2004-06-30 | 89 |
| K023565 | OXICHECK | CCL | 2003-03-28 | 156 |
| K000959 | CRITERION 60 OR PM 60 | CAP | 2000-06-22 | 90 |
| K992101 | CRITERION 40 OR PM 40 | CAP | 2000-01-06 | 198 |
| K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | BYE | 1999-03-09 | 252 |
Recalls
openFDA lists no recalls under a recalling firm named Caradyne, Ltd..
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 Caradyne, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Caradyne, Ltd.” (first 1999, latest 2004), across 4 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 Caradyne, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caradyne, Ltd. is 156 days.
Which FDA product codes appear under Caradyne, Ltd.?
The most frequent FDA product codes under this applicant name are CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 2); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1); BZD (Ventilator, Non-Continuous (Respirator), 1).
Next steps
- See all 5 Caradyne, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAP, Caradyne, Ltd.'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.