Atlas FDA

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

Cytori Therapeutics, Inc. · Predicate Candidate Screening

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

125 daysmedian FDA review time
217 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132815PUREGRAFT 50 SYSTEMCytori Therapeutics, Inc.2014-01-241370
K113255PUREGRAFT 850/PURE SYSTEMCytori Therapeutics, Inc.2012-03-071250
K092923CYTORI PUREGRAFT 250/PURE SYSTEMCytori Therapeutics, Inc.2010-01-061050
K072587CYTORI AFT SYSTEMCytori Therapeutics, Inc.2007-12-10870
K063235CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENTCytori Therapeutics, Inc.2007-01-24910
K060482CYTORI CELUTION CELL CONCENTRATION DEVICECytori Therapeutics, Inc.2006-09-282170

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