Baxa Tubing Sets (for Pharmacy Pump)
FDA 510(k) K872743 · Baxa Corp., Sub. of Cook Group, Inc.
510(k) numberK872743
Submission
- Device name
- Baxa Tubing Sets (for Pharmacy Pump)
- Applicant
- Baxa Corp., Sub. of Cook Group, Inc.
Englewood, CO, US - Received
- July 13, 1987
- Decision date
- October 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910257 | Baxa Pca InfusorMEA · Traditional | 11/07/1991SE |
| K903159 | Valve Controller for Micromacro CompounderLHI · Traditional | 11/07/1990SE |
| K904225 | KwikmixLHI · Traditional | 11/05/1990SE |
| K900585 | Tubing Sets for Baxa Exacta-Med Pharmacy PumpLHI · Traditional | 04/18/1990SE |
| K873875 | Baxa Exacta-Med Pharmacy PumpFRN · Traditional | 11/24/1987SE |
| K844904 | Cytosafe NeedleLHI · Traditional | 02/22/1985SE |
| K832347 | Twofer NeedleLHI · Traditional | 09/12/1983SE |
| K832332 | Vented I.V. Transfer NeedleLHI · Traditional | 09/12/1983SE |
| K832312 | I.V. Transfer NeedleLHI · Traditional | 09/12/1983SE |
| K832254 | Baxa AddisealKPE · Traditional | 07/26/1983SE |
Questions and answers
When was Baxa Tubing Sets (for Pharmacy Pump) cleared by the FDA?
Baxa Tubing Sets (for Pharmacy Pump) (K872743) received a 510(k) decision of Substantially Equivalent on October 9, 1987, 88 days after the submission was received.
What is the product code of K872743?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.