Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bardy Diagnostics, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
88 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2023-11-22 | 56 | 0 |
| K210036 | Carnation Ambulatory Monitor (CAM) | Bardy Diagnostics, Inc. | 2021-02-05 | 30 | 0 |
| K200870 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2020-05-01 | 30 | 0 |
| K192556 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-10-17 | 30 | 0 |
| K191471 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-08-30 | 88 | 0 |
| K191000 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-05-16 | 30 | 0 |
| K143067 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2014-12-22 | 59 | 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