# Hans Rudolph, Inc.

- Location (FDA's records): Kansas City, MO
- FDA decisions: 11 (1979–2008): 11 510(k) clearances
- Product codes: BZD (3), KGB (2), BSJ (2), CCM (1), BZC (1), BYG (1), CBK (1)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 9 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed, Ltd.: 5 (https://510kreport.com/company/resmed)
- Respironics, Inc.: 4 (https://510kreport.com/company/respironics)

## Firms that cite its devices most
- Tiara Medical Systems, Inc.: 1 (https://510kreport.com/company/tiara-medical-systems)
- Resmed, Ltd.: 1 (https://510kreport.com/company/resmed)
- Respcare, Inc.: 1 (https://510kreport.com/company/respcare)
- Sensor Medics Corp.: 1 (https://510kreport.com/company/sensor-medics)
- Innomed Technologies, Inc./Respcare, Inc.: 1 (https://510kreport.com/company/innomed-technologies-respcare)

## Its most-cited devices
- K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit (2002), cited by 3
- K030515: Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks (2003), cited by 2
- K030822: 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks (2003), cited by 2
- K962848: Hans Rudolph Nasal Cpap Mask (1996), cited by 1
- K071149: Hri 6500, 6600 and 6700 Series V2MASKS (2008), cited by 1

## Recent decisions
- K071149: Hri 6500, 6600 and 6700 Series V2MASKS (Feb 1, 2008)
- K030822: 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks (Jun 3, 2003)
- K030515: Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks (May 2, 2003)
- K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit (Aug 13, 2002)
- K962848: Hans Rudolph Nasal Cpap Mask (Oct 16, 1996)
- K960401: Ultimate Seal (Jun 20, 1996)
- K946077: Directional Control Valves Inflatable Balloon-Type and Controllers (Sep 15, 1995)
- K945894: Mask, Gas, Anesthetic (Jan 27, 1995)

Source page: https://510kreport.com/company/hans-rudolph