Sunrise Medical, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Sunrise Medical, Inc.” (first 1992, latest 2013), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 77 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 | 1 | 233 |
| 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | 10 | 10 |
| IOR | Wheelchair, Mechanical | 9 | 9 |
| BZD | Ventilator, Non-Continuous (Respirator) | 6 | 6 |
| CAW | Generator, Oxygen, Portable | 3 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 1 | 1 |
Review panels
- Physical Medicine (20)
- Anesthesiology (11)
- General Hospital (2)
Most recent Sunrise Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123975 | QUICKIE & ZIPPIE SERIES | IOR | 2013-08-16 | 233 |
| K093070 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES | MNS | 2010-01-26 | 118 |
| K091919 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST | BZD | 2009-09-28 | 90 |
| K082209 | DEVILBISS DV5M SMARTLINK SYSTEM | BZD | 2008-10-28 | 84 |
| K081468 | DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES | CAW | 2008-08-25 | 90 |
| K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES | CAW | 2007-10-01 | 133 |
| K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | IOR | 2007-09-10 | 38 |
| K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES | BZD | 2007-09-07 | 79 |
| K062701 | QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR | ITI | 2006-09-25 | 14 |
| K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS | ITI | 2006-03-17 | 17 |
23 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2009-02-02.
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, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
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 Technologies, Inc. (18 510(k)s)
- Sunrise Medical Hhg, Inc. (10 510(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, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Sunrise Medical, Inc.” (first 1992, latest 2013), 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sunrise Medical, Inc. is 77 days.
Which FDA product codes appear under Sunrise Medical, Inc.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 10); IOR (Wheelchair, Mechanical, 9); BZD (Ventilator, Non-Continuous (Respirator), 6).
Next steps
- See all 33 Sunrise Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Sunrise Medical, 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.