PLQ · Class II · 21 CFR 876.5985

FDA Product Code PLQ: Enzyme Packed Cartridge

Hydrolyze Fats In Enteral Formula.

Leading manufacturers include Alcresta Therapeutics, Inc. and Alcresta, Inc..

8
Total
7
Cleared
150d
Avg days
2015
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 73d recently vs 176d historically

FDA 510(k) Cleared Enzyme Packed Cartridge Devices (Product Code PLQ)

8 devices
1–8 of 8
Cleared Apr 17, 2025
RELiZORB (100300/100301)
K250499
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 15, 2025
RELiZORB (100300/ 100301)
K243284
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 21, 2023
RELiZORB®
K232784
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 101d
Cleared Aug 30, 2023
Enzyme Packed Cartridge - RELiZORB
K231156
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 128d
Cleared Dec 04, 2019
RELiZORB
K191379
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 195d
Cleared Jul 12, 2017
Relizorb
K163057
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 253d
Cleared Jun 30, 2016
Relizorb
K161247
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 58d
Not Cleared Nov 20, 2015
RELIZORB
DEN150001
Alcresta, Inc.
Gastroenterology & Urology · 322d

About Product Code PLQ - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code PLQ since 2015, with 7 receiving FDA clearance (average review time: 150 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - PLQ Product Code

Recent submissions under PLQ have taken an average of 73 days to reach a decision - down from 176 days historically, suggesting improved FDA processing for this classification.

PLQ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →