# Cadwell Industries, Inc.

- Location (FDA's records): Kennewick, WA
- FDA decisions: 13 (2014–2026): 13 510(k) clearances
- Product codes: GWQ (4), GWF (2), OMA (1), IKN (1), OLT (1), OLZ (1), MNR (1), OLV (1), GXY (1)
- 510(k) review time since 2016: median 146 days, against 177 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 28 (5 its own); citations of its devices by later devices: 10 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Natus Medical, Inc.: 2 (https://510kreport.com/company/natus-medical)
- Carefusion 209, Inc.: 2 (https://510kreport.com/company/carefusion-209)
- Persyst Development Corporation: 2 (https://510kreport.com/company/persyst-development)
- Inomed Medizintechnik GmbH: 1 (https://510kreport.com/company/inomed-medizintechnik)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Digitimer, Ltd.: 1 (https://510kreport.com/company/digitimer)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)

## Firms that cite its devices most
- Inomed Medizintechnik GmbH: 2 (https://510kreport.com/company/inomed-medizintechnik)
- Neurofield, Inc.: 1 (https://510kreport.com/company/neurofield)
- Natus Neurology Incorporated: 1 (https://510kreport.com/company/natus-neurology)
- Safeop Surgical, Inc.: 1 (https://510kreport.com/company/safeop-surgical)

## Its most-cited devices
- K162199: Cascade IOMAX Intraoperative Monitor (2017), cited by 4
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent (2017), cited by 2
- K133355: Cadwell Flex Eeg/PSG (2014), cited by 1
- K161027: Cadwell AmpliScan (2016), cited by 1
- K180269: Cadwell Apollo System (2018), cited by 1
- K201819: Cadwell Apollo System (2020), cited by 1

## Recent decisions
- K261442: Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array (Jun 26, 2026)
- K250851: Hypnos (369054-200) (Dec 14, 2025)
- K242424: Bluebird Single-Use Respiratory Effort Belt (Dec 18, 2024)
- K230415: Cadwell Guardian (Aug 17, 2023)
- K201819: Cadwell Apollo System (Sep 29, 2020)
- K192624: ApneaTrak (Feb 20, 2020)
- K190760: Cadwell Bolt Software (Nov 23, 2019)
- K181466: Cadwell Zenith System (Sep 1, 2018)

Source page: https://510kreport.com/company/cadwell-industries