Product code FKG
- Device name
- Tray, Start/Stop (Including Contents), Dialysis
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | J.J. Skinner, Inc. | 1995-05-03 |
| K871630 | KITS AND TRAYS FOR DIALYSIS USE | Dove Medical Supplies | 1987-05-26 |
| K833780 | CAPD PREP KIT | Professional Dialysis Products | 1984-02-09 |
| K802361 | DIALYIS START CARE KIT | Med-Pak Corp. | 1981-01-16 |
| K792207 | PERIDIAL PERITONEAL DIALYSIS TRAY | Cutter Laboratories, Inc. | 1979-12-10 |
| K790353 | ACUTE RENAL DIALYSIS TRAY | Argon Medical Corp. | 1979-04-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10195594678760 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-10-11 |
| 10195594756833 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-07-29 |
| 10195594609108 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-04-25 |
| 10195594606190 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-04-04 |
| 10195594607500 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-03-25 |
| 10195594523855 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-03 |
| 10195594426422 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-12-14 |
| 10195594068387 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-11-24 |
| 10195594083274 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-10-25 |
| 10195594335939 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-10-08 |
| 10193489860450 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-09-01 |
| 10195594170585 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-06-24 |
| 10195594147808 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-06-11 |
| 10195594059316 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-05-13 |
| 10195594033514 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-05-10 |
| 10195594028787 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-04-13 |
| 10193489198102 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-09-22 |
| 10193489197990 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-08-19 |
| 10193489197822 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-07-20 |
| 10193489197495 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-06-08 |
| 10193489196115 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-23 |
| 10193489196078 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-23 |
| 10193489192735 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-23 |
| 10193489191769 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 10193489191691 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 10193489191639 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 10193489191622 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 10193489191011 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 10193489191004 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 10193489190694 | MEDLINE | CENTURION MEDICAL PRODUCTS CORPORATION | 2020-04-03 |