Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1922553

FEI Number

1922553

Entity Name

HANS RUDOLPH, INC.

City/State/Country

Shawnee, KS, US

Establishment Address

8325 COLE PKWY, Shawnee, KS 66227, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANS RUDOLPH, INC. (Owner Number: 1922553)

Owner / Operator Contact Address

8325 Cole Parkway, --, Shawnee, KS 66227, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030822

PMA Number

N/A

All Registered Proprietary Names

Metro Seal NASAL CPAP MASK RUDOLPH F. R. C. CALIBRATION AID RUDOLPH CALIBRATED VARIABLE VOLUME RUDOLPH CALIBRATED SUPER SYRINGE Oro-Nasal CPAP Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2008-01-24
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	1996-07-16
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	1992-12-22
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-28

Official Correspondent

KEVIN RUDOLPH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HANS RUDOLPH, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1922553. Last updated year: 2026. Please use registration number 1922553 when referencing this establishment in official correspondence.