De Novo · Granted
GrantedRelizorb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcresta, Inc. · PLQ Enzyme Packed Cartridge
Granted on Nov 20, 2015 as a new device type through De Novo after a 322-day review. 7 later devices descend from it.
- Decided
- Nov 20, 2015
- Review
- 322 days
- Class
- Class II
- Product code
- PLQ
- Recalls
- None
7 later devices descend from it, 3 citing it directly.
- This deviceDEN150001 RelizorbAlcresta, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK161247 RelizorbAlcresta Therapeutics, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK163057 RelizorbAlcresta Therapeutics, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK191379 RELiZORBAlcresta Therapeutics, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK231156 Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK232784 RELiZORB®Alcresta Therapeutics, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161247RelizorbAlcresta Therapeutics, Inc. · 2016 · cites it directly6descendants
- K163057RelizorbAlcresta Therapeutics, Inc. · 2017 · cites it directly5descendants
- K191379RELiZORBAlcresta Therapeutics, Inc. · 2019 · cites it directly4descendants
- K231156Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. · 2023 · 2 generations on3descendants
- K232784RELiZORB®Alcresta Therapeutics, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150001 | Relizorb | Alcresta, Inc. | 2015 | — |
| +1 | K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016 | — |
| +1 | K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017 | — |
| +1 | K191379 | RELiZORB | Alcresta Therapeutics, Inc. | 2019 | — |
| +2 | K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023 | — |
| +3 | K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K161247 (Alcresta Therapeutics, Inc., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PLQ devicesPLQ Enzyme Packed Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
indicated for use in adults to hydrolyze fats in enteral formula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150001 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150001: Relizorb.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150001
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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