Atlas FDA

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

Cosmed Srl — Predicate Candidate Screening

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

285 daysmedian FDA review time
379 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl2020-02-063150
K162515COSMED K5 Wearable Metabolic TechnologyCosmed Srl2017-06-202850
K120146QUARK SERIESCosmed Srl2012-12-113280
K093174SPIROPALMCosmed Srl2010-02-261410
K071533FITMATE SERIESCosmed Srl2007-09-281150
K040549COSMED PONY FXCosmed Srl2004-09-282100
K020745COSMED MICROQUARKCosmed Srl2003-01-023010
K014262COSMED QUARK C12/QUARK T12Cosmed Srl2002-03-26890
K001174COSMED QUARKCosmed Srl2001-01-112750
K963373COSMED K4Cosmed Srl1997-09-103790

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