Product Code: PLQ FDA class 2 21 CFR 876.5985

Enzyme Packed Cartridge

Gastroenterology, Urology

The Enzyme Packed Cartridge (product code PLQ) is a Class 2 gastroenterology and urology device designed to hydrolyze fats in enteral formula, regulated under 876.5985. It requires 510(k) clearance and is used in the context of enteral nutrition delivery. The device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: PLQ
Device Class: FDA class 2
Regulation Number: 876.5985
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Hydrolyze fats in enteral formula.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250499	RELiZORB (100300/100301)	Apr 17, 2025	Substantially Equivalent	Alcresta Therapeutics, Inc.
K243284	RELiZORB (100300/ 100301)	Jan 15, 2025	Substantially Equivalent	Alcresta Therapeutics, Inc.
K232784	RELiZORB®	Dec 21, 2023	Substantially Equivalent	Alcresta Therapeutics, Inc.
K231156	Enzyme Packed Cartridge - RELiZORB	Aug 30, 2023	Substantially Equivalent	Alcresta Therapeutics, Inc.
K191379	RELiZORB	Dec 04, 2019	Substantially Equivalent	Alcresta Therapeutics, Inc.
K163057	Relizorb	Jul 12, 2017	Substantially Equivalent	Alcresta Therapeutics, Inc.
K161247	Relizorb	Jun 30, 2016	Substantially Equivalent	Alcresta Therapeutics, Inc.
DEN150001	RELIZORB	Nov 20, 2015	Unknown	Alcresta, Inc.