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

Siemens Medical Laboratories, Inc. · Predicate Candidate Screening

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

57 daysmedian FDA review time

113 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K910971	Z XT RADIATION THERAPY TREATMENT TABLE	Siemens Medical Laboratories, Inc.	1991-05-03	57	0
K903139	BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)	Siemens Medical Laboratories, Inc.	1990-11-07	113	1
K894230	PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)	Siemens Medical Laboratories, Inc.	1989-08-28	70	0
K882729	MEVATRON, M 2 CLASS	Siemens Medical Laboratories, Inc.	1988-09-19	75	35
K875272	SONOLINE CF	Siemens Medical Laboratories, Inc.	1988-02-18	56	0
K862339	MEVATRON KD-2	Siemens Medical Laboratories, Inc.	1986-10-29	131	15
K854609	MEVAMATIC 3	Siemens Medical Laboratories, Inc.	1986-02-21	95	0
K852907	SIEMENS MEVATRON ME	Siemens Medical Laboratories, Inc.	1985-09-19	72	0
K812032	MEVATRON 67E	Siemens Medical Laboratories, Inc.	1981-08-18	29	0
K791967	MEVATRON 74X MEDICAL LINEAR ACCELERATOR	Siemens Medical Laboratories, Inc.	1979-11-16	45	0
K790747	MEVATRON 74	Siemens Medical Laboratories, Inc.	1979-05-04	18	0
K790688	MEVATRON 67	Siemens Medical Laboratories, Inc.	1979-04-23	13	1
K790388	MEVATRON 60	Siemens Medical Laboratories, Inc.	1979-03-26	28	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