Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunrise Medical (Us), LLC · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220213 | Empulse R90 | Sunrise Medical (Us), LLC | 2022-03-30 | 63 | 0 |
| K172384 | Quickie(r) Q700-UP M | Sunrise Medical (Us), LLC | 2018-01-16 | 161 | 0 |
| K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zip | Sunrise Medical (Us), LLC | 2016-07-14 | 189 | 0 |
| K142457 | Quickie, Zippie | Sunrise Medical (Us), LLC | 2014-12-18 | 107 | 1 |
| K133855 | BREEZY ELEGANCE | Sunrise Medical (Us), LLC | 2014-01-31 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda