Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reflectance Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
227 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141496 | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | Reflectance Medical, Inc. | 2014-08-04 | 59 | 0 |
| K133923 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | Reflectance Medical, Inc. | 2014-04-11 | 109 | 0 |
| K130079 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER | Reflectance Medical, Inc. | 2013-07-19 | 186 | 0 |
| K122645 | MOBILE CAREGUIDE 2100 OXIMETER | Reflectance Medical, Inc. | 2012-12-05 | 97 | 0 |
| K113656 | CAREGUIDE OXIMETER | Reflectance Medical, Inc. | 2012-07-26 | 227 | 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