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

Datex-Engstrom, Inc. — Predicate Candidate Screening

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

152 daysmedian FDA review time

375 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983366	TRIP TONOMETRY CATHETER, 16F	Datex-Engstrom, Inc.	1998-12-23	90	0
K982091	CS/3 COMPACT AIRWAY MODULE, M-COVX	Datex-Engstrom, Inc.	1998-12-22	190	0
K981378	DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1	Datex-Engstrom, Inc.	1998-11-03	201	0
K973985	AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)	Datex-Engstrom, Inc.	1998-10-30	375	8
K980362	MRI COMPATIBLE MONITOR AND ACCESSORIES	Datex-Engstrom, Inc.	1998-06-30	152	0
K974792	CS/3(TM) MONITORS*	Datex-Engstrom, Inc.	1998-06-02	162	0
K980384	TRIP TONOMETRY CATHETER, 18F	Datex-Engstrom, Inc.	1998-05-01	88	0
K974747	CS/3 ARRHYTHMIA WORKSTATION	Datex-Engstrom, Inc.	1998-04-23	125	0
K974101	DATEX-ENGSTROM NETWORK	Datex-Engstrom, Inc.	1998-02-06	99	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