Cleared Traditional

K250499 - RELiZORB (100300/100301)

K250499 is an FDA 510(k) clearance for RELiZORB (100300/100301), manufactured by Alcresta Therapeutics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PLQ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K250499 · Alcresta Therapeutics, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
56d
Days
Class 2
Risk

K250499 is an FDA 510(k) clearance for the RELiZORB (100300/100301). Classified as Enzyme Packed Cartridge (product code PLQ), Class II - Special Controls.

Submitted by Alcresta Therapeutics, Inc. (Waltham, US). The FDA issued a Cleared decision on April 17, 2025 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5985 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alcresta Therapeutics, Inc. devices

FDA 510(k) Submission Details - K250499

510(k) Number K250499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2025
Decision Date April 17, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 131d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLQ Device Classification - Class 2, Special Controls

Product Code PLQ Enzyme Packed Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5985
Definition Hydrolyze Fats In Enteral Formula.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PLQ Enzyme Packed Cartridge

All 7
Devices cleared under the same product code (PLQ) and FDA review panel - the closest regulatory comparables to K250499.
RELiZORB (100300/ 100301)
K243284 · Alcresta Therapeutics, Inc. · Jan 2025
RELiZORB®
K232784 · Alcresta Therapeutics, Inc. · Dec 2023
Enzyme Packed Cartridge - RELiZORB
K231156 · Alcresta Therapeutics, Inc. · Aug 2023
RELiZORB
K191379 · Alcresta Therapeutics, Inc. · Dec 2019
Relizorb
K163057 · Alcresta Therapeutics, Inc. · Jul 2017
Relizorb
K161247 · Alcresta Therapeutics, Inc. · Jun 2016