510(k) · Cleared
ClearedRELiZORB (100300/100301)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcresta Therapeutics, Inc. · PLQ Enzyme Packed Cartridge
Cleared on Apr 17, 2025 as substantially equivalent to K243284 (Alcresta Therapeutics, Inc., 2025) after a 56-day review. Its family tree reaches back 7 generations to 2015.
- Decided
- Apr 17, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- PLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN150001 (2015). No later device cites it as a predicate yet.
- Root · 7 generations backDEN150001 RelizorbAlcresta, Inc. · 2015
- 6 generations backK161247 RelizorbAlcresta Therapeutics, Inc. · 2016
- 5 generations backK163057 RelizorbAlcresta Therapeutics, Inc. · 2017
- 4 generations backK191379 RELiZORBAlcresta Therapeutics, Inc. · 2019
- 3 generations backK231156 Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. · 2023
- 2 generations backK232784 RELiZORB®Alcresta Therapeutics, Inc. · 2023
- 1 generation backK243284 RELiZORB (100300/ 100301)Alcresta Therapeutics, Inc. · 2025
- This deviceK250499 RELiZORB (100300/100301)Alcresta Therapeutics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN150001 | Relizorb | Alcresta, Inc. | 2015 | — |
| −6 | K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016 | — |
| −5 | K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017 | — |
| −4 | K191379 | RELiZORB | Alcresta Therapeutics, Inc. | 2019 | — |
| −3 | K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023 | — |
| −2 | K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023 | — |
| −1 | K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | 2025 | — |
| 0 (this device) | K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLQ device
- #1 K243284 RELiZORB (100300/ 100301)score 13.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243284 | RELiZORB (100300/ 100301)Summary page 5…Transplant Devices (DHTA3A) 3. Predicate Device Device Trade/Proprietary Name RELiZORB® 510(k) Number K243284 Device Common Name Enzyme Packed Cartridge Regulation Number 21 CFR 876.5985… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All PLQ devicesPLQ Enzyme Packed Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PLQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLQ
Too few PLQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PLQ
No recall names PLQ since 2007.
Adverse event reports per year · PLQ
2in 2025
MAUDE reports naming product code PLQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
RELiIZORB is indicated for use in pediatric (including neonates and infants) and adult patients to
hydrolyze fats during enteral feeding.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250499: RELiZORB (100300/100301).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250499
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026