510(k) · Cleared
ClearedRELiZORB
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 Dec 4, 2019 as substantially equivalent to DEN150001 (Alcresta, Inc., 2015) and 2 other predicates after a 195-day review. Its family tree reaches back 3 generations to 2015. 4 later devices descend from it.
- Decided
- Dec 4, 2019
- Review
- 195 days
- Class
- Class II
- Product code
- PLQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN150001 (2015). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN150001 RelizorbAlcresta, Inc. · 2015
- 2 generations backK161247 RelizorbAlcresta Therapeutics, Inc. · 2016
- 1 generation backK163057 RelizorbAlcresta Therapeutics, Inc. · 2017
- This deviceK191379 RELiZORBAlcresta Therapeutics, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK231156 Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK232784 RELiZORB®Alcresta Therapeutics, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK243284 RELiZORB (100300/ 100301)Alcresta Therapeutics, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK250499 RELiZORB (100300/100301)Alcresta Therapeutics, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K231156Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. · 2023 · cites it directly3descendants
- K232784RELiZORB®Alcresta Therapeutics, Inc. · 2023 · 2 generations on2descendants
- K243284RELiZORB (100300/ 100301)Alcresta Therapeutics, Inc. · 2025 · 3 generations on1descendant
- K250499RELiZORB (100300/100301)Alcresta Therapeutics, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN150001 | Relizorb | Alcresta, Inc. | 2015 | — |
| −2 | K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016 | — |
| −1 | K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017 | — |
| 0 (this device) | K191379 | RELiZORB | Alcresta Therapeutics, Inc. | 2019 | — |
| +1 | K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023 | — |
| +2 | K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023 | — |
| +3 | K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | 2025 | — |
| +4 | K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | DEN150001 | RelizorbSummary page 4…ification Name: Enzyme packed cartridge Subject device 21 CFR 876.5985, Product code PLQ classification Predicate Device: RELiZORB™ DEN150001, K161247, K163057 Predicate device 21 CFR 876.5985, Product code PLQ classification Device Description:… | 2015 |
| * | K161247 | RelizorbSummary page 4…ame: Enzyme packed cartridge Subject device 21 CFR 876.5985, Product code PLQ classification Predicate Device: RELiZORB™ DEN150001, K161247, K163057 Predicate device 21 CFR 876.5985, Product code PLQ classification Device Description: RELiZORB… | 2016 |
| * | K163057 | RelizorbSummary page 4…Enzyme packed cartridge Subject device 21 CFR 876.5985, Product code PLQ classification Predicate Device: RELiZORB™ DEN150001, K161247, K163057 Predicate device 21 CFR 876.5985, Product code PLQ classification Device Description: RELiZORB is a sing… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231156 | Enzyme Packed Cartridge - RELiZORB | 2023 | 3 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231156 (Alcresta Therapeutics, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate DEN150001.
How does its category compare?
All PLQ devicesPLQ Enzyme Packed Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
RELiZORB™ is indicated for use with pediatric (ages 5 years and above) and adult patients to
hydrolyze fats in enteral formula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191379: RELiZORB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191379
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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