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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Carefusion 2200, Inc. · Predicate Candidate Screening

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

140 daysmedian FDA review time
287 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061Carefusion 2200, Inc.2021-03-04280
K163615Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc.2017-05-041330
K162432Multi-Link X2 ECG Cable and Lead Wire SystemCarefusion 2200, Inc.2017-01-181400
K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc.2016-08-251574
K153554Genesis Low Temperature Reusable Rigid Container SystemCarefusion 2200, Inc.2016-03-21980
K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Carefusion 2200, Inc.2016-02-012870
K142529Genesis Reusable Rigid Container SystemCarefusion 2200, Inc.2015-01-081212
K140850GENESIS REUSABLE RIGID CONTAINER SYSTEMCarefusion 2200, Inc.2014-08-271460
K140761KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIANCarefusion 2200, Inc.2014-04-21260
K113407SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORSCarefusion 2200, Inc.2012-09-072940
K112535GENESIS REUSABLE RIGID CONTAINER SYSTEMCarefusion 2200, Inc.2012-04-272390
K110257DIAMOND-FLEX(R) GRASPERSCarefusion 2200, Inc.2011-05-06980

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