Hydrocision, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Hydrocision, Inc.” (first 1998, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Since 2017 the median was 68 days, against 108 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 68 |
| 2020 | 1 | 27 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 387 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hydrocision, Inc. took a median 68 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 9 | 9 |
| FQH | Lavage, Jet | 3 | 3 |
Review panels
- Orthopedic (9)
- General Hospital (3)
Most recent Hydrocision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241990 | SpineSite Endoscope System | HRX | 2025-07-30 | 387 |
| K200729 | HydroCision SpineJet System | HRX | 2020-04-16 | 27 |
| K190804 | HydroCision TenJet Device | HRX | 2019-06-05 | 68 |
| K041233 | ARTHROJET XT | HRX | 2004-07-28 | 79 |
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 | HRX | 2003-09-16 | 32 |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | FQH | 2003-05-09 | 340 |
| K020688 | HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR | HRX | 2002-04-03 | 30 |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | FQH | 2001-06-22 | 28 |
| K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | HRX | 2000-11-24 | 80 |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | FQH | 2000-03-31 | 345 |
2 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-09-07.
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 Hydrocision, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03487250: Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System (Completed, started 2016-08-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hydrocision, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Hydrocision, Inc.” (first 1998, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hydrocision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hydrocision, Inc. is 74 days. Since 2017: 68 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hydrocision, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 9); FQH (Lavage, Jet, 3).
Next steps
- See all 12 Hydrocision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Hydrocision, 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.