Sunrise Medical (Us), LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sunrise Medical (Us), LLC” (first 2014, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 107 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 |
|---|---|---|
| 2014 | 2 | 75 |
| 2015 | 0 | — |
| 2016 | 1 | 189 |
| 2017 | 0 | — |
| 2018 | 1 | 161 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 63 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sunrise Medical (Us), LLC took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 3 | 3 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
| IPL | Wheelchair, Standup | 1 | 1 |
Review panels
Most recent Sunrise Medical (Us), LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220213 | Empulse R90 | ITI | 2022-03-30 | 63 |
| K172384 | Quickie(r) Q700-UP M | IPL | 2018-01-16 | 161 |
| K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) | ITI | 2016-07-14 | 189 |
| K142457 | Quickie, Zippie | ITI | 2014-12-18 | 107 |
| K133855 | BREEZY ELEGANCE | IOR | 2014-01-31 | 43 |
Recalls
11 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2021-07-08.
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.
- Sunrise Medical, Inc. (33 510(k)s)
- Sunrise Technologies, Inc. (18 510(k)s)
- Sunrise Medical Hhg, Inc. (10 510(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 (Us), LLC?
FDA lists 5 510(k) clearances under the applicant name “Sunrise Medical (Us), LLC” (first 2014, latest 2022), across 3 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 Sunrise Medical (Us), LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sunrise Medical (Us), LLC is 107 days.
Which FDA product codes appear under Sunrise Medical (Us), LLC?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 3); IOR (Wheelchair, Mechanical, 1); IPL (Wheelchair, Standup, 1).
Next steps
- See all 5 Sunrise Medical (Us), LLC clearances with predicates and recalls
- Run predicate analysis for product code ITI, Sunrise Medical (Us), LLC'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.