Snap-Lock Additive Cap #Sl 200

Q: What is the product code of K854032?

The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.

FDA 510(k) K854032 · Williams Medical Co.

Substantially Equivalent

510(k) numberK854032

Submission

Device name: Snap-Lock Additive Cap #Sl 200
Applicant: Williams Medical Co.
Anaheim, CA, US
Received: October 1, 1985
Decision date: November 1, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

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
K891159	Sodium Bicarbonate, U.S.P.KPO · Traditional	04/07/1989SE
K854034	Snap-Lock Additive Cap #Sl 300KPE · Traditional	11/06/1985SE
K854033	Snap-Lock Additive Cap #SL400KPE · Traditional	11/06/1985SE
K854031	Snap-Lock Additive Cap #SL100KPE · Traditional	11/06/1985SE

Questions and answers

When was Snap-Lock Additive Cap #Sl 200 cleared by the FDA?

Snap-Lock Additive Cap #Sl 200 (K854032) received a 510(k) decision of Substantially Equivalent on November 1, 1985, 31 days after the submission was received.

What is the product code of K854032?

The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.