Hans Rudolph, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Hans Rudolph, Inc.” (first 1979, latest 2008), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 2 | 2 |
| KGB | Mask, Oxygen, Non-Rebreathing | 2 | 2 |
| BYG | Mask, Oxygen | 1 | 1 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| CCM | Plethysmograph, Pressure | 1 | 1 |
Review panels
- Anesthesiology (11)
Most recent Hans Rudolph, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071149 | HRI 6500, 6600 AND 6700 SERIES V2MASKS | BZD | 2008-02-01 | 283 |
| K030822 | 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS | BZD | 2003-06-03 | 81 |
| K030515 | HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS | CBK | 2003-05-02 | 72 |
| K020759 | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT | BZD | 2002-08-13 | 159 |
| K962848 | HANS RUDOLPH NASAL CPAP MASK | BYG | 1996-10-16 | 86 |
| K960401 | ULTIMATE SEAL | KGB | 1996-06-20 | 143 |
| K946077 | DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS | BZC | 1995-09-15 | 276 |
| K945894 | MASK, GAS, ANESTHETIC | BSJ | 1995-01-27 | 56 |
| K933583 | NONREBREATHING VALVE | KGB | 1994-01-03 | 164 |
| K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | BSJ | 1993-08-20 | 108 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hans Rudolph, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hans Biomed Corporation (9 510(k)s)
- Hans Hermann GmbH (2 510(k)s)
- Hans J. Brouwers & Assoc. (2 510(k)s)
- Hans Gevder (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hans Rudolph, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Hans Rudolph, Inc.” (first 1979, latest 2008), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hans Rudolph, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hans Rudolph, Inc. is 108 days.
Which FDA product codes appear under Hans Rudolph, Inc.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 3); BSJ (Mask, Gas, Anesthetic, 2); KGB (Mask, Oxygen, Non-Rebreathing, 2).
Next steps
- See all 11 Hans Rudolph, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Hans Rudolph, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.