Data / Medical devices / United States / Hans Rudolph, Inc.
Hans Rudolph, Inc.: FDA-registered device maker in Shawnee, KS, United States, 2 510(k) clearances
Hans Rudolph, Inc. is registered with the FDA (registration 1922553) in Shawnee, KS, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 3, 2003. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1922553
- Address
- 8325 Cole Pkwy, Shawnee, KS, United States, 66227
- Owner or operator
- HANS RUDOLPH, INC. (1922553)
- Roles
- Manufacturer
- First device listed
- December 22, 1992
- Registered through
- 2027
- Brand names listed
- Metro Seal, NASAL CPAP MASK, Oro-Nasal CPAP Mask, Oro-Nasal NIV Mask, RUDOLPH CALIBRATED SUPER SYRINGE, RUDOLPH CALIBRATED VARIABLE VOLUME, RUDOLPH F. R. C. CALIBRATION AID, V2 FACE MASK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Volume, Gas | BXW | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2003 | K030822 | 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS | BZD | Substantially Equivalent | Hans Rudolph, Inc. | accessdata.fda.gov |
| May 2, 2003 | K030515 | HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS | CBK | Substantially Equivalent | Hans Rudolph, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Volume, Gas
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Ventilator, Continuous, Facility Use
- All makers of Mask, Oxygen
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Tape And Bandage, Adhesive
Updated June 3, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.