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

Tz Medical, Inc. · Predicate Candidate Screening

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

203 daysmedian FDA review time

366 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252772	Arc Adjustable Radial Cuff Compression Device	Tz Medical, Inc.	2026-05-22	262	0
K173563	ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE	Tz Medical, Inc.	2018-01-10	54	0
K163322	TZ SKULL PIN Adult	Tz Medical, Inc.	2017-02-23	90	0
K102507	AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR	Tz Medical, Inc.	2011-06-13	285	0
K062577	V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC	Tz Medical, Inc.	2006-12-15	106	0
K040208	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAN	Tz Medical, Inc.	2004-05-11	102	0
K021421	PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE	Tz Medical, Inc.	2003-04-18	350	0
K001634	CARDIOSENTRY EVENT MONITOR, MODEL 8470-01	Tz Medical, Inc.	2000-12-21	209	0
K993205	BOOKER BOX, MODEL PAD 5010	Tz Medical, Inc.	2000-07-20	300	0
K983196	PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)	Tz Medical, Inc.	1999-09-15	369	1
K983232	PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPAR	Tz Medical, Inc.	1999-09-15	366	0
K982228	FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 L	Tz Medical, Inc.	1999-01-14	203	0
K973132	EZ HOLD 1 LBS., EZ HOLD 2 LBS	Tz Medical, Inc.	1998-01-12	144	0
K964888	HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II	Tz Medical, Inc.	1997-02-28	84	0
K923930	ELECTROCARDIOGRAPH TRANSMITTER	Tz Medical, Inc.	1992-10-21	77	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