Atlas FDA

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

Tronomed, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
213 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952659TRONOMATE PATIENT CABLE & LEADWIRE SYSTEMTronomed, Inc.1996-01-112130
K853303LIFELINC LEADWIRETronomed, Inc.1985-09-18430
K853452LIFE LINC PATIENT CABLETronomed, Inc.1985-09-10250
K841092HIGH PRESSURE FLEX. CONNECTING TUBINGTronomed, Inc.1985-07-244980
K7921263&4 WAY PLASTIC STERILE STPCKS. PKG.Tronomed, Inc.1980-01-16840
K792124TANDEM ASSEMBLED 3&4 WAY STOPCOCKSTronomed, Inc.1980-01-16840
K7921253&4 WAY PLASTIC STOPCOCKS, NONSTERILETronomed, Inc.1980-01-16840
K792128STERILE EXTENSION TUBES INDIV. PKG.Tronomed, Inc.1980-01-16840
K792127PLAS. STCK. W/EXTENSION TUBE/STERILETronomed, Inc.1980-01-16840
K771645ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRETronomed, Inc.1977-10-18500
K771027ELECTROCARDIOGRAPHIC PATIENT CABLESTronomed, Inc.1977-07-05270
K770884ELHCTROCARDIOGRAPHIC CONNECTING WIRESTronomed, Inc.1977-05-2370

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