Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cadwell Industries, Inc. — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

167 daysmedian FDA review time

243 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261442	Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reu	Cadwell Industries, Inc.	2026-06-26	57	0
K250851	Hypnos (369054-200)	Cadwell Industries, Inc.	2025-12-14	268	0
K242424	Bluebird Single-Use Respiratory Effort Belt	Cadwell Industries, Inc.	2024-12-18	125	0
K230415	Cadwell Guardian	Cadwell Industries, Inc.	2023-08-17	182	0
K201819	Cadwell Apollo System	Cadwell Industries, Inc.	2020-09-29	90	0
K192624	ApneaTrak	Cadwell Industries, Inc.	2020-02-20	150	0
K190760	Cadwell Bolt Software	Cadwell Industries, Inc.	2019-11-23	243	0
K181466	Cadwell Zenith System	Cadwell Industries, Inc.	2018-09-01	89	0
K180269	Cadwell Apollo System	Cadwell Industries, Inc.	2018-07-17	167	0
K162199	Cascade IOMAX Intraoperative Monitor	Cadwell Industries, Inc.	2017-03-02	209	2
K162383	Cadwell Sierra Summit, Cadwell Sierra Ascent	Cadwell Industries, Inc.	2017-03-01	188	0
K161027	Cadwell AmpliScan	Cadwell Industries, Inc.	2016-11-08	210	0
K133355	CADWELL FLEX EEG/PSG	Cadwell Industries, Inc.	2014-01-29	90	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda