# Caradyne, Ltd.

- Location (FDA's records): Mccordsville, IN
- FDA decisions: 5 (1999–2004): 5 510(k) clearances
- Product codes: CAP (2), CCL (1), BZD (1), BYE (1)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 12 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Canadian Monaghan, Ltd.: 4 (https://510kreport.com/company/canadian-monaghan)
- Vital Signs, Inc.: 3 (https://510kreport.com/company/vital-signs)
- Ceramatec, Inc.: 1 (https://510kreport.com/company/ceramatec)
- Eme (Electro Medical Equipment), Ltd.: 1 (https://510kreport.com/company/eme-electro-medical-equipment)
- Vapotherm, Inc.: 1 (https://510kreport.com/company/vapotherm)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)

## Firms that cite its devices most
- Maxtec, LLC: 2 (https://510kreport.com/company/maxtec)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)
- Vygon Corp.: 1 (https://510kreport.com/company/vygon)
- Pulmodyne: 1 (https://510kreport.com/company/pulmodyne)
- Airon Corporation: 1 (https://510kreport.com/company/airon)
- Drw Medical: 1 (https://510kreport.com/company/drw-medical)
- Vortran Medical Technology 1, Inc.: 1 (https://510kreport.com/company/vortran-medical-technology-1)
- Childrens Medical Ventures, LLC: 1 (https://510kreport.com/company/childrens-medical-ventures)

## Its most-cited devices
- K992101: Criterion 40 or PM 40 (2000), cited by 4
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH (1999), cited by 4
- K040862: Guardian Neonate Cpap/Humidification System (2004), cited by 2
- K023565: Oxicheck (2003), cited by 1
- K000959: Criterion 60 or PM 60 (2000), cited by 1

## Recent decisions
- K040862: Guardian Neonate Cpap/Humidification System (Jun 30, 2004)
- K023565: Oxicheck (Mar 28, 2003)
- K000959: Criterion 60 or PM 60 (Jun 22, 2000)
- K992101: Criterion 40 or PM 40 (Jan 6, 2000)
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH (Mar 9, 1999)

Source page: https://510kreport.com/company/caradyne