Atlas FDA

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

FEW · Predicate Candidate Screening

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

132 daysmedian FDA review time
309 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140085UNIVERSA PERCULTANEOUS DRAINAGE CATHETERCook Incorporated2014-11-183090
K070879BARD MALECOT AND PEZZER DRAINSC.R. Bard, Inc.2007-04-24250
K981258MANAN MALECOT BASKET DRAINAGE CATHETERMedical Device Technologies, Inc.1998-04-22160
K954147MANAN MALECOT BASKET DRAINAGE CATHETERManan Medical Products, Inc.1996-03-262030
K954116SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIPTechnical Products, Inc.1995-11-061090
K920423OLYMPIC SMART SCALE CARE CENTEROlympic Medical Corp.1992-06-111320

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