Sunrise Medical Hhg, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Sunrise Medical Hhg, Inc.” (first 1998, latest 2008), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
| NFB | Conserver, Oxygen | 1 | 1 |
Review panels
Most recent Sunrise Medical Hhg, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083249 | QUICKIE RHYTHM | ITI | 2008-12-23 | 49 |
| K012437 | DEVILBISS SLEEP RECORDER MODEL # RM60 | MNR | 2002-07-16 | 350 |
| K020329 | DEVILBISS PD1000 | NFB | 2002-06-19 | 139 |
| K020900 | DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM | BTT | 2002-06-03 | 75 |
| K011229 | DEVILBISS 9000 SERIES CPAP, MODEL 9001 | BZD | 2001-07-11 | 79 |
| K003626 | DEVILBISS HUMIDIFIER | BTT | 2001-05-04 | 161 |
| K993492 | DEVILBISS NEBULIZER MODEL 800 | CAF | 2000-04-21 | 189 |
| K991722 | DEVILBISS 5 LITER OXYGEN CONCENTRATOR | CAW | 1999-11-03 | 167 |
| K982304 | DEVILBISS SUCTION UNIT | JCX | 1998-09-25 | 86 |
| K981602 | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR | BTA | 1998-07-17 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Sunrise Medical Hhg, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sunrise Medical Hhg, Inc. (a text match, not an official crosswalk):
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.
- Sunrise Medical, Inc. (33 510(k)s)
- Sunrise Technologies, Inc. (18 510(k)s)
- Sunrise Medical (Us), LLC (5 510(k)s)
- Sunrise Medical Quickie Designs, Inc. (4 510(k)s)
- Sunrise SA (2 510(k)s)
- Sunrise International Business (1 510(k)s)
- Sunrise (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sunrise Medical Hhg, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Sunrise Medical Hhg, Inc.” (first 1998, latest 2008), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sunrise Medical Hhg, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sunrise Medical Hhg, Inc. is 112 days.
Which FDA product codes appear under Sunrise Medical Hhg, Inc.?
The most frequent FDA product codes under this applicant name are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); BZD (Ventilator, Non-Continuous (Respirator), 1).
Next steps
- See all 10 Sunrise Medical Hhg, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Sunrise Medical Hhg, 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.