Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sulzer Carbomedics, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
307 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | Sulzer Carbomedics, Inc. | 2002-12-17 | 84 | 0 |
| K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS | Sulzer Carbomedics, Inc. | 2002-06-13 | 279 | 0 |
| K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | Sulzer Carbomedics, Inc. | 2002-04-23 | 22 | 0 |
| K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS | Sulzer Carbomedics, Inc. | 2001-01-25 | 206 | 0 |
| K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM | Sulzer Carbomedics, Inc. | 1999-12-29 | 89 | 0 |
| K992056 | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 | Sulzer Carbomedics, Inc. | 1999-10-12 | 116 | 0 |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Sulzer Carbomedics, Inc. | 1998-08-04 | 235 | 0 |
| K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE | Sulzer Carbomedics, Inc. | 1998-04-14 | 307 | 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