C.G.H. Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “C.G.H. Medical, Inc.” (first 1991, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 401 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 5 | 5 |
| CAN | Regulator, Pressure, Gas Cylinder | 2 | 2 |
| FJG | Dialyzer, Parallel Flow | 1 | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Review panels
Most recent C.G.H. Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941708 | COBE CENTRYSYSTEM CS500 DIALYZER | FJI | 1995-05-12 | 401 |
| K933818 | GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER | KDI | 1995-01-25 | 539 |
| K925522 | CENTRYSYSTEM 3 WITH CHARTS/BP OPTION | KOC | 1994-09-30 | 697 |
| K920757 | FILTRAL HEMODIALYZERS | KDI | 1994-08-05 | 898 |
| K931720 | LUNDIA ALPHA 700 HEMODIALYZER | KDI | 1994-07-07 | 456 |
| K924437 | HEMOSPAL KIT B22 / MULTIFLOW 60 KIT | KDI | 1994-06-27 | 664 |
| K940601 | GAMBRO BICART 720G | KPO | 1994-03-22 | 40 |
| K915154 | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | CAN | 1992-05-27 | 195 |
| K914271 | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) | CAN | 1992-04-13 | 202 |
| K915504 | GAMBRO LUNDIA ALPHA HEMODIALYZERS | FJG | 1992-03-06 | 88 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named C.G.H. Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under C.G.H. Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “C.G.H. Medical, Inc.” (first 1991, latest 1995), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by C.G.H. Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name C.G.H. Medical, Inc. is 401 days.
Which FDA product codes appear under C.G.H. Medical, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 5); CAN (Regulator, Pressure, Gas Cylinder, 2); FJG (Dialyzer, Parallel Flow, 1).
Next steps
- See all 11 C.G.H. Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, C.G.H. Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.