Panels › General Hospital › Product code FPK · Class 2
Tubing, Fluid Delivery
Regulation 880.5440
0510(k)s in 12 months (64 all time)
0recalls in 12 months (28 all time)
18recalls that name a 510(k)
Top companies in FPK
| Company | 510(k)s | Recalls |
|---|---|---|
| MOOG Medical Devices Group | 0 | 14 |
| Mentor Texas, Inc | 0 | 9 |
| Churchill Corp. | 3 | 0 |
| Clinical Connections, Inc. | 3 | 0 |
| 3M Company | 2 | 0 |
| Degania Silicone , Ltd. | 2 | 0 |
| Distronic Sterile Products, Inc. | 2 | 0 |
| Harvard Laboratories | 2 | 0 |
| Hospira, Inc. | 1 | 1 |
| Medrad, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2025 | Merit Medical Systems, Inc. High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C Open, Classified |
FPK | K883718 |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) Open, Classified |
FPK | K160651 |
| Jan 11, 2017 | Hospira Inc. Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free
Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. Terminated |
FPK | K941214 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4176, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port Positive Pressure Package Assembly, product code: 340-4133, Method of Sterilization using Ethylene Oxide.
The Curlin A Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly, product code: 340-4173, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 340-4166, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with disposa Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged, product code: 340-4165, Method of Sterilization using Ethylene Oxide. Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4144, Method of Sterilization using Ethylene Oxide.
The Curlin Ambu Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve Packaged Assembly, product code: 340-4137, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Inf Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130-V, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System wi Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128-V, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System wi Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly, product code: 340-4126, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System w Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4115, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with Terminated |
FPK | K981816 |
| May 30, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product code: 340-4114, Method of Sterilization using Ethylene Oxide.
The Curlin Ambulatory Infusion Pump System with di Terminated |
FPK | K981816 |
| Sep 5, 2008 | Mentor Texas, Inc Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global Sta Terminated |
FPK | K935642 |
| Jul 20, 2004 | Stryker Instruments, Instruments Div. Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000. Terminated |
FPK | None listed |
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