Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Estech, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
136 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133017 | ESTECH COBRA(R) GENESIS BIPOLAR CLAMP | Estech, Inc. | 2013-10-07 | 11 | 0 |
| K053021 | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | Estech, Inc. | 2006-01-26 | 92 | 0 |
| K052081 | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA | Estech, Inc. | 2005-12-16 | 136 | 0 |
| K051749 | COBRA SURGICAL SYSTEM | Estech, Inc. | 2005-09-13 | 76 | 0 |
| K041599 | COBRA ADHERE SURGICAL SYSTEM | Estech, Inc. | 2004-07-27 | 43 | 0 |
| K032632 | REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH | Estech, Inc. | 2003-10-22 | 57 | 0 |
| K990573 | ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA | Estech, Inc. | 1999-03-11 | 16 | 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