Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C.G.H. Medical, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
401 daysmedian FDA review time
697 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941708 | COBE CENTRYSYSTEM CS500 DIALYZER | C.G.H. Medical, Inc. | 1995-05-12 | 401 | 0 |
| K933818 | GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER | C.G.H. Medical, Inc. | 1995-01-25 | 539 | 0 |
| K925522 | CENTRYSYSTEM 3 WITH CHARTS/BP OPTION | C.G.H. Medical, Inc. | 1994-09-30 | 697 | 0 |
| K920757 | FILTRAL HEMODIALYZERS | C.G.H. Medical, Inc. | 1994-08-05 | 898 | 0 |
| K931720 | LUNDIA ALPHA 700 HEMODIALYZER | C.G.H. Medical, Inc. | 1994-07-07 | 456 | 0 |
| K924437 | HEMOSPAL KIT B22 / MULTIFLOW 60 KIT | C.G.H. Medical, Inc. | 1994-06-27 | 664 | 0 |
| K940601 | GAMBRO BICART 720G | C.G.H. Medical, Inc. | 1994-03-22 | 40 | 0 |
| K915154 | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | C.G.H. Medical, Inc. | 1992-05-27 | 195 | 0 |
| K914271 | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) | C.G.H. Medical, Inc. | 1992-04-13 | 202 | 0 |
| K915504 | GAMBRO LUNDIA ALPHA HEMODIALYZERS | C.G.H. Medical, Inc. | 1992-03-06 | 88 | 0 |
| K911603 | HEMOSPAL KIT B22 | C.G.H. Medical, Inc. | 1991-08-07 | 119 | 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