Atlas FDA

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

Rnk Products, Inc. · Predicate Candidate Screening

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

70 daysmedian FDA review time
112 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132405PPA/BT-RB STETHOSCOPERnk Products, Inc.2013-10-11700
K132560PCP-USB STETHOSCOPERnk Products, Inc.2013-10-11570
K102893PCP/PC STETHOSCOPERnk Products, Inc.2011-01-201120
K081032TR-USB TELEPHONIC STETHOSCOPERnk Products, Inc.2008-06-06560
K072026RNK ELECTRONIC STETHOSCOPERnk Products, Inc.2007-10-26940

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