Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flowcardia, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
138 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MOD | Flowcardia, Inc. | 2010-02-17 | 211 | 0 |
| K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 | Flowcardia, Inc. | 2009-06-19 | 102 | 0 |
| K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 | Flowcardia, Inc. | 2009-05-29 | 30 | 0 |
| K091119 | MODIFICATION TO THE CROSSER SYSTEM | Flowcardia, Inc. | 2009-05-15 | 28 | 0 |
| K080849 | MICROSHEATH LP AND LP-AT | Flowcardia, Inc. | 2008-07-25 | 121 | 0 |
| K080765 | CROSSER LP SYSTEM | Flowcardia, Inc. | 2008-06-20 | 94 | 0 |
| K073289 | MICROSHEATH XL CATHETERS | Flowcardia, Inc. | 2008-01-11 | 51 | 0 |
| K072776 | THE CROSSER SYSTEM | Flowcardia, Inc. | 2007-12-07 | 70 | 1 |
| K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, M | Flowcardia, Inc. | 2007-01-19 | 116 | 0 |
| K051580 | VP SHEATH | Flowcardia, Inc. | 2005-10-31 | 138 | 0 |
| K051062 | VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIR | Flowcardia, Inc. | 2005-07-15 | 80 | 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