Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carbomedics, Inc. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
172 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970375 | ANNULOFLO SYSTEM | Carbomedics, Inc. | 1997-07-25 | 172 | 0 |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | Carbomedics, Inc. | 1997-02-19 | 90 | 0 |
| K962154 | CARBOMEDICS HANDLE | Carbomedics, Inc. | 1996-08-27 | 84 | 0 |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Carbomedics, Inc. | 1996-04-29 | 54 | 0 |
| K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT | Carbomedics, Inc. | 1996-04-25 | 64 | 0 |
| K960169 | CARBOMEDICS VALVE TESTER | Carbomedics, Inc. | 1996-04-15 | 90 | 1 |
| K955588 | VASCUTEK GRAFT SIZER SET | Carbomedics, Inc. | 1996-03-07 | 91 | 0 |
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Carbomedics, Inc. | 1995-11-29 | 204 | 0 |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Carbomedics, Inc. | 1995-06-20 | 85 | 0 |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Carbomedics, Inc. | 1994-07-06 | 26 | 0 |
| K934951 | VALVE SIZER | Carbomedics, Inc. | 1993-12-10 | 53 | 0 |
| K842893 | DORR HIP PROSTHESIS, ACETABULAR COMPON | Carbomedics, Inc. | 1984-11-08 | 108 | 0 |
| K842360 | DORR HIP PROSTHESIS FEMORAL COMPONENT | Carbomedics, Inc. | 1984-10-02 | 117 | 0 |
| K833404 | BDH BIPOLAR FEMORAL COMPONENT A3 | Carbomedics, Inc. | 1984-03-02 | 154 | 0 |
| K834040 | MINATURE PRESSURE TRANSDUCER | Carbomedics, Inc. | 1984-02-10 | 79 | 0 |
| K833403 | BDH UNIPOLAR FEMORAL COMPONENT A2 | Carbomedics, Inc. | 1984-01-10 | 102 | 0 |
| K833468 | BDH UNIVERSAL HIP SYSTEM SURGEON | Carbomedics, Inc. | 1983-12-27 | 82 | 0 |
| K811101 | HYDROXYLAPATITE | Carbomedics, Inc. | 1981-11-20 | 213 | 1 |
| K810382 | HYDROXYLAPATITE ALVEOLAR RIDGE MAIN | Carbomedics, Inc. | 1981-03-20 | 35 | 0 |
| K791416 | PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT | Carbomedics, Inc. | 1979-10-09 | 75 | 0 |
| K791491 | BIOLITE CARBON COATED DENTAL IMPLANT | Carbomedics, Inc. | 1979-09-04 | 29 | 0 |
| K791237 | PYROLITE CARBON ENDOSSEOUS DENTAL IMPL | Carbomedics, Inc. | 1979-08-28 | 53 | 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