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

Ranir, LLC — Predicate Candidate Screening

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

42 daysmedian FDA review time

140 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K133423	REST ASSURED EXTRA COMFORT NITE PROTECTOR	Ranir, LLC	2013-12-20	42
K120103	REST ASSURED GENERATION III DENTAL PROTECTOR	Ranir, LLC	2012-02-03	22
K112879	REST ASSURED READY TO WEAR NITE PROTECTOR	Ranir, LLC	2012-01-27	119
K103004	SNORE GUARD	Ranir, LLC	2011-02-25	140
K102118	SNORE GUARD ADVANCE	Ranir, LLC	2010-09-08	42
K094020	GRIND NO MORE GENERATION II	Ranir, LLC	2010-01-25	27
K091175	GRIND NO MORE VERSION 2 AND 3	Ranir, LLC	2009-05-08	16
K063229	REST ASSURED NITE PROTECTOR	Ranir, LLC	2006-12-19	55

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