Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hydrocision, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
345 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 | 387 | 0 |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020-04-16 | 27 | 0 |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | 2019-06-05 | 68 | 0 |
| K041233 | ARTHROJET XT | Hydrocision, Inc. | 2004-07-28 | 79 | 0 |
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CUR | Hydrocision, Inc. | 2003-09-16 | 32 | 2 |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | Hydrocision, Inc. | 2003-05-09 | 340 | 0 |
| K020688 | HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR | Hydrocision, Inc. | 2002-04-03 | 30 | 0 |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | Hydrocision, Inc. | 2001-06-22 | 28 | 0 |
| K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | Hydrocision, Inc. | 2000-11-24 | 80 | 0 |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | Hydrocision, Inc. | 2000-03-31 | 345 | 0 |
| K993009 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY | Hydrocision, Inc. | 1999-10-25 | 48 | 0 |
| K982266 | HYDROCISION ARTHROJET SYSTEM | Hydrocision, Inc. | 1998-09-25 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda