FDA product code PLQ: Enzyme Packed Cartridge
PLQ is the FDA product code for enzyme packed cartridge. It is a Class II device, regulated under 21 CFR 876.5985 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under PLQ, 4 in the last five years. The average 510(k) review took 126 days (median 101); 73 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Hydrolyze fats in enteral formula.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Packed Cartridge |
| Device class | Class II |
| Regulation | 21 CFR 876.5985 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PLQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 253 |
| 2019 | 1 | 195 |
| 2023 | 2 | 114 |
| 2025 | 2 | 73 |
Compare with all 510(k) review times · Search every PLQ clearance
Top PLQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alcresta Therapeutics, Inc. | 7 | 2025-04-17 |
Most recent PLQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250499 | Alcresta Therapeutics, Inc. | RELiZORB (100300/100301) | 2025-04-17 | 56 |
| K243284 | Alcresta Therapeutics, Inc. | RELiZORB (100300/ 100301) | 2025-01-15 | 90 |
| K232784 | Alcresta Therapeutics, Inc. | RELiZORB® | 2023-12-21 | 101 |
| K231156 | Alcresta Therapeutics, Inc. | Enzyme Packed Cartridge - RELiZORB | 2023-08-30 | 128 |
| K191379 | Alcresta Therapeutics, Inc. | RELiZORB | 2019-12-04 | 195 |
Recalls for PLQ devices
openFDA lists no recalls for product code PLQ.
Frequently asked questions
What is FDA product code PLQ?
PLQ is the FDA product code for enzyme packed cartridge. It is a Class II device, regulated under 21 CFR 876.5985 and reviewed by the Gastroenterology and Urology panel.
What device class is PLQ?
Class II, regulation 21 CFR 876.5985. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLQ?
Across 7 cleared submissions the average was 126 days from receipt to decision (median 101).
Which companies have the most PLQ clearances?
Alcresta Therapeutics, Inc. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code PLQ
- Run a recall and safety report across every PLQ manufacturer
- Watch product code PLQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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