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

Spacelabs Healthcare — Predicate Candidate Screening

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

127 daysmedian FDA review time

277 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K150329	elance Vital Signs Monitor, Central Monitor Software	Spacelabs Healthcare	2015-11-05	268	0
K141156	SPACELABS HEALTHCARE TELEMETRY RECEIVER	Spacelabs Healthcare	2014-09-09	127	4
K122146	XHIBIT CENTRAL STATION, MODEL 96102	Spacelabs Healthcare	2013-04-22	277	3
K130112	CAPNO MODULE, 92517	Spacelabs Healthcare	2013-03-21	64	0
K121017	CAPNOGRAPHY PAD (92516)	Spacelabs Healthcare	2012-07-13	100	0
K112729	BLEASE700/900 SERIES VENTILATORS	Spacelabs Healthcare	2012-06-11	265	1
K121480	ARIATELE TELEMETRY TRANSMITTER (96281)	Spacelabs Healthcare	2012-06-06	19	2
K113051	SPACELABS ARKON ANESTHESIA WORKSTATION	Spacelabs Healthcare	2012-03-22	161	4
K112173	SPEACELABS MULTIGAS MODULE	Spacelabs Healthcare	2011-10-05	69	1
K110779	SPACELABS SMART DISCLOSURE SYSTEM	Spacelabs Healthcare	2011-04-19	29	2

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