Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ViOptix, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
339 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | ViOptix, Inc. | 2025-06-26 | 125 | 0 |
| K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024-02-28 | 124 | 0 |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022-05-03 | 28 | 0 |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019-09-16 | 84 | 0 |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017-11-16 | 339 | 0 |
| K133983 | INTRA. OX HANDHELD TISSUE OXIMETER | Vioptix, Inc. | 2014-09-12 | 259 | 0 |
| K141234 | ODISSEY TISSUE OXIMETER | Vioptix, Inc. | 2014-07-01 | 49 | 0 |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Vioptix, Inc. | 2009-04-17 | 32 | 0 |
| K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | Vioptix, Inc. | 2005-01-10 | 104 | 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