Atlas FDA

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

Larsen & Toubro Limited — Predicate Candidate Screening

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

58 daysmedian FDA review time
133 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103686STAR 50 NLarsen & Toubro Limited2011-03-15880
K103763STELLAR 300Larsen & Toubro Limited2011-03-11780
K093017STELLAR 300Larsen & Toubro Limited2010-04-292120
K092153SKYLINE 55, MODEL VER 1Larsen & Toubro Limited2009-11-201270
K090172STAR 55 MODEL 100Larsen & Toubro Limited2009-06-051330
K090443PLANET 55, MODEL 100Larsen & Toubro Limited2009-06-051050
K082685GALAXY 55Larsen & Toubro Limited2008-09-26110
K081552SKYLINE 55Larsen & Toubro Limited2008-07-31580
K080173STAR 55Larsen & Toubro Limited2008-02-08150
K071472PLANET 55Larsen & Toubro Limited2007-09-211150
K061816GALAXYLarsen & Toubro Limited2006-07-12140
K060058STELLAR 404TLarsen & Toubro Limited2006-01-20110
K051608STAR 50 MONITORING SYSTEMLarsen & Toubro Limited2005-06-29120
K043370PLANET 50 MONITORING SYSTEMLarsen & Toubro Limited2005-02-15690
K042560STELLAR 404 MONITORING SYSTEMLarsen & Toubro Limited2004-10-06150
K040409LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYLarsen & Toubro Limited2004-02-2790
K032871PLANET MONITORING SYSTEMLarsen & Toubro Limited2003-11-10560
K032867STAR (LUNAR SERIES) MONITORING SYSTEMLarsen & Toubro Limited2003-11-10560

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