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

Defibtech, LLC — Predicate Candidate Screening

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

195 daysmedian FDA review time

409 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211289	RMU-2000 Automated Chest Compression System	Defibtech, LLC	2021-11-09	195	1
K141809	RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM	Defibtech, LLC	2014-10-27	112	0
K131525	SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	Defibtech, LLC	2014-04-24	331	0
K113787	DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORI	Defibtech, LLC	2013-01-04	379	0
K121853	DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCES	Defibtech, LLC	2012-12-13	171	0
K081259	DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIE	Defibtech, LLC	2009-06-15	409	0
K033896	DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS	Defibtech, LLC	2004-06-16	183	1
K033144	DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES	Defibtech, LLC	2003-11-13	44	0
K013896	SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBR	Defibtech, LLC	2002-06-19	208	5

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