Aqua Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Aqua Medical, Inc.” (first 2019, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 109 days. Since 2017 the median was 109 days, against 118 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 |
|---|---|---|
| 2019 | 1 | 182 |
| 2020 | 0 | — |
| 2021 | 2 | 30 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 220 |
| 2025 | 1 | 109 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aqua Medical, Inc. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 5 | 5 |
Review panels
Most recent Aqua Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251226 | Aqua Medical RF Vapor Ablation System | KNS | 2025-08-08 | 109 |
| K241271 | Aqua Medical RF Vapor Ablation System | KNS | 2024-12-12 | 220 |
| K213627 | RF Vapor System | KNS | 2021-12-17 | 30 |
| K211282 | Aqua Medical RF Vapor System | KNS | 2021-05-27 | 30 |
| K183595 | Aqua Medical RF Vapor System | KNS | 2019-06-21 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Aqua Medical, 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 Aqua Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07355270: A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) (Recruiting, started 2026-04-01)
- NCT06724822: RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus (Active not recruiting, started 2024-11-14)
- NCT06655740: Safety, Tolerability, and Effectiveness of Duodenal Mucosal RF Vapor Ablation for Insulin Elimination in Type-2 Diabetes (Active not recruiting, started 2024-10-01)
- NCT05887635: Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus (Recruiting, started 2023-09-02)
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.
- Aqua-Air Medical Devices, Inc. (1 510(k)s)
- Aqua Ark, Inc. (1 510(k)s)
- Aqua Care Corp. (1 510(k)s)
- Aqua Massage Intl., Inc. (1 510(k)s)
- Aqua-Med Systems, Inc. (1 510(k)s)
- Aqua Sciences, Inc. (1 510(k)s)
- Aqua-Tools (1 510(k)s)
- Aqua Water Treatment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aqua Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Aqua Medical, Inc.” (first 2019, 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 Aqua Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aqua Medical, Inc. is 109 days. Since 2017: 109 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aqua Medical, Inc.?
The most frequent FDA product codes under this applicant name are KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 5).
Next steps
- See all 5 Aqua Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNS, Aqua Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.