Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiofocus, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
194 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | 2016-02-24 | 194 | 0 |
| K013201 | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR | Cardiofocus, Inc. | 2002-03-18 | 174 | 0 |
| K013901 | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) | Cardiofocus, Inc. | 2001-12-20 | 24 | 0 |
| K011988 | SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C | Cardiofocus, Inc. | 2001-09-20 | 86 | 0 |
| K993834 | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C | Cardiofocus, Inc. | 2000-02-04 | 84 | 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