Cd Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Cd Medical, Inc.” (first 1985, latest 1994), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| FKP | System, Dialysate Delivery, Single Patient | 3 | 3 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| FIF | Set, Dialysis, Single Needle With Uni-Directional Pump | 1 | 1 |
| FIP | Subsystem, Water Purification | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
Review panels
Most recent Cd Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925654 | CD HOME DIALYSERVICE HEMODIALYSIS TRAY | KOC | 1994-03-30 | 506 |
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST | FKP | 1991-04-09 | 82 |
| K901520 | WURTZ CHOLEY CLIP (TM) | GBZ | 1990-06-26 | 85 |
| K894106 | DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST | FIP | 1989-11-08 | 152 |
| K884353 | ULTRX(TM) 850 ARTIFICIAL KIDNEY | KDI | 1988-12-08 | 52 |
| K880459 | 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE | FKP | 1988-04-13 | 70 |
| K873279 | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE | FIF | 1987-10-23 | 67 |
| K864784 | SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS | FJK | 1987-01-20 | 43 |
| K862304 | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM | FKQ | 1986-09-09 | 84 |
| K853513 | DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY | FKP | 1985-11-06 | 77 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cd 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 Cd Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Cd Medical, Inc.” (first 1985, latest 1994), across 8 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 Cd Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cd Medical, Inc. is 77 days.
Which FDA product codes appear under Cd Medical, Inc.?
The most frequent FDA product codes under this applicant name are FKP (System, Dialysate Delivery, Single Patient, 3); KOC (Accessories, Blood Circuit, Hemodialysis, 2); FIF (Set, Dialysis, Single Needle With Uni-Directional Pump, 1).
Next steps
- See all 11 Cd Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FKP, Cd 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.