Hans Rudolph, Inc.
Shawnee, KS, US
HANS RUDOLPH, INC. appears in FDA device records in Shawnee, KS. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Hans Rudolph, Inc. between 1979 and 2008. The busiest year on record is 1995, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071149 | HRI 6500, 6600 AND 6700 SERIES V2MASKS | BZD | Substantially Equivalent | |
| K030822 | 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS | BZD | Substantially Equivalent | |
| K030515 | HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS | CBK | Substantially Equivalent | |
| K020759 | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT | BZD | Substantially Equivalent | |
| K962848 | HANS RUDOLPH NASAL CPAP MASK | BYG | Substantially Equivalent | |
| K960401 | ULTIMATE SEAL | KGB | Substantially Equivalent | |
| K946077 | DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS | BZC | Substantially Equivalent | |
| K945894 | MASK, GAS, ANESTHETIC | BSJ | Substantially Equivalent | |
| K933583 | NONREBREATHING VALVE | KGB | Substantially Equivalent | |
| K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | BSJ | Substantially Equivalent | |
| K791705 | 4200 PNEUMATIC MOUTH SHUTTER | CCM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1922553 | 1922553 | HANS RUDOLPH, INC. | 8325 COLE PKWY, Shawnee, KS 66227 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain