Baxa Adli Seal
FDA 510(k) K813435 · Baxa Corp., Sub. of Cook Group, Inc.
510(k) numberK813435
Submission
- Device name
- Baxa Adli Seal
- Applicant
- Baxa Corp., Sub. of Cook Group, Inc.
Mchenry, IL, US - Received
- December 8, 1981
- Decision date
- December 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
Other 510(k)s with product code KPE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 04/02/2026SE |
| K251980 | ClaveQS BagKPE · Traditional | Icu Medical, Inc. | 03/20/2026SE |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | Fresenius Kabi AG | 01/09/2026SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | Epic Medical Pte. , Ltd. | 08/01/2025SE |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional | Technoflex Sas. | 04/18/2025SE |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection SiteKPE · Special | Epic Medical Pte. , Ltd. | 06/21/2024SE |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110)KPE · Traditional | Epic Medical Pte. , Ltd. | 09/01/2023SE |
| K222622 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 02/16/2023SE |
| K210749 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 08/19/2021SE |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional | Gilero, LLC | 05/06/2021SE |
More from Gilero, LLC
| 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 |
| K872743 | Baxa Tubing Sets (for Pharmacy Pump)FMF · Traditional | 10/09/1987SE |
| 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 |
Questions and answers
When was Baxa Adli Seal cleared by the FDA?
Baxa Adli Seal (K813435) received a 510(k) decision of Substantially Equivalent on December 18, 1981, 10 days after the submission was received.
What is the product code of K813435?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.