Alcresta Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Alcresta Therapeutics, Inc.” (first 2016, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 101 days. Since 2017 the median was 114 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 58 |
| 2017 | 1 | 253 |
| 2018 | 0 | — |
| 2019 | 1 | 195 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 114 |
| 2024 | 0 | — |
| 2025 | 2 | 73 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alcresta Therapeutics, Inc. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLQ | Enzyme Packed Cartridge | 7 | 7 |
Review panels
Most recent Alcresta Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250499 | RELiZORB (100300/100301) | PLQ | 2025-04-17 | 56 |
| K243284 | RELiZORB (100300/ 100301) | PLQ | 2025-01-15 | 90 |
| K232784 | RELiZORB® | PLQ | 2023-12-21 | 101 |
| K231156 | Enzyme Packed Cartridge - RELiZORB | PLQ | 2023-08-30 | 128 |
| K191379 | RELiZORB | PLQ | 2019-12-04 | 195 |
| K163057 | Relizorb | PLQ | 2017-07-12 | 253 |
| K161247 | Relizorb | PLQ | 2016-06-30 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Alcresta Therapeutics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Alcresta Therapeutics, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02750501: Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study (Completed, started 2016-07-20)
- NCT02598128: Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb) (Completed, started 2015-11)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alcresta, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alcresta Therapeutics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Alcresta Therapeutics, Inc.” (first 2016, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alcresta Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alcresta Therapeutics, Inc. is 101 days. Since 2017: 114 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alcresta Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are PLQ (Enzyme Packed Cartridge, 7).
Next steps
- See all 7 Alcresta Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PLQ, Alcresta Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.