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

Tecnomed, Inc. · Predicate Candidate Screening

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

29 daysmedian FDA review time

70 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K892226	TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE	Tecnomed, Inc.	1989-04-26	22
K854203	TEC 2720 MAMEX DC MAG	Tecnomed, Inc.	1986-03-06	141
K820307	TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE	Tecnomed, Inc.	1982-03-05	29
K820306	RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC	Tecnomed, Inc.	1982-03-05	29
K827124	RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC	Tecnomed, Inc.	1982-03-05	29
K827126	TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE	Tecnomed, Inc.	1982-03-05	29
K820305	RALCO COLLIMATORS, MANUAL RADIOGRAPHIC	Tecnomed, Inc.	1982-03-04	28
K827125	RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC	Tecnomed, Inc.	1982-03-04	28
K811197	SUPERIX 120	Tecnomed, Inc.	1981-06-09	40
K811196	ALLMEC 90/15	Tecnomed, Inc.	1981-06-09	40
K811195	ARGOSTAT	Tecnomed, Inc.	1981-06-09	40
K803103	TECHNY REX 3000 MOBILE X-RAY UNIT	Tecnomed, Inc.	1981-01-22	44
K792326	HILO TRANS-X TRAUMA TRANSPORT	Tecnomed, Inc.	1980-01-28	70
K792327	INTEGRON	Tecnomed, Inc.	1979-12-20	31
K781066	PLURIX C; RADIOGRAPHIC TABLE	Tecnomed, Inc.	1978-07-17	21
K781068	AUTOMATIC FILM PROCESSORIO M. R80	Tecnomed, Inc.	1978-07-17	21
K781065	PLURIMAT;RADIOGRAPHIC TUBE MOUNT	Tecnomed, Inc.	1978-07-17	21
K781067	PLURIX B; RADIOGRAPHIC TABLE	Tecnomed, Inc.	1978-07-17	21

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