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

Deroyal — Predicate Candidate Screening

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

98 daysmedian FDA review time

163 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K041416	EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER	Deroyal	2004-07-02	36	0
K033057	DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE	Deroyal	2003-11-20	52	0
K031408	DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE	Deroyal	2003-10-15	163	0
K030908	DEROYAL SURGICAL DRAPES BACKTABLE COVER	Deroyal	2003-08-11	140	0
K020753	DEROYAL SURGICAL, UMBILICUP	Deroyal	2002-06-13	98	2

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