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

Hans Rudolph, Inc. — Predicate Candidate Screening

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

108 daysmedian FDA review time
276 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071149HRI 6500, 6600 AND 6700 SERIES V2MASKSHans Rudolph, Inc.2008-02-012830
K0308227600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKHans Rudolph, Inc.2003-06-03810
K030515HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKSHans Rudolph, Inc.2003-05-02720
K0207597600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 Hans Rudolph, Inc.2002-08-131590
K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.1996-10-16860
K960401ULTIMATE SEALHans Rudolph, Inc.1996-06-201430
K946077DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTRHans Rudolph, Inc.1995-09-152760
K945894MASK, GAS, ANESTHETICHans Rudolph, Inc.1995-01-27560
K933583NONREBREATHING VALVEHans Rudolph, Inc.1994-01-031640
K932147NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONEHans Rudolph, Inc.1993-08-201080
K7917054200 PNEUMATIC MOUTH SHUTTERHans Rudolph, Inc.1979-10-04370

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