Atlas FDA

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

Stellartech Research Corp. — Predicate Candidate Screening

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

26 daysmedian FDA review time
90 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061544STELLARTECH 100 COAGULATION SYSTEMStellartech Research Corp.2006-10-131300
K050831STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100Stellartech Research Corp.2005-04-12110
K042909STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-23Stellartech Research Corp.2004-11-12220
K041383STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-2Stellartech Research Corp.2004-06-14200
K040240STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230Stellartech Research Corp.2004-04-01580
K032721MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100Stellartech Research Corp.2003-10-06330
K032452MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100Stellartech Research Corp.2003-08-21100
K032062STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-23Stellartech Research Corp.2003-07-29260
K023765STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230Stellartech Research Corp.2002-11-29170
K013139STELLARTECH COAGULATION SYSTEMStellartech Research Corp.2001-12-18900
K994173STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLAStellartech Research Corp.2000-01-20410

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