Aspire Bariatrics, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Aspire Bariatrics, Inc.” (first 2018, latest 2018), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. 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 |
|---|---|---|
| 2018 | 2 | 99 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aspire Bariatrics, Inc. took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| OYF | Aspiration Therapy System | 1 | 0 |
Review panels
Most recent Aspire Bariatrics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182248 | Aspire Venting Tube | KNT | 2018-11-13 | 85 |
| K180725 | Aspire Introducer Needle | KNT | 2018-07-11 | 113 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150024 | PMA | AspireAssist | 2016-06-14 |
Recalls
openFDA lists no recalls under a recalling firm named Aspire Bariatrics, 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 Aspire Bariatrics, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01766037: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study (Completed, started 2012-11-13)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aspire Bariatrics, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Aspire Bariatrics, Inc.” (first 2018, latest 2018), plus 1 PMA decision, across 2 product codes 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 Aspire Bariatrics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aspire Bariatrics, Inc. is 99 days.
Which FDA product codes appear under Aspire Bariatrics, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 2); OYF (Aspiration Therapy System, 1).
Next steps
- See all 2 Aspire Bariatrics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Aspire Bariatrics, 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.