FDA product code OMR: Vessel Guard Or Cover
OMR is the FDA product code for vessel guard or cover. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel. FDA has cleared 10 510(k) submissions under OMR, from 5 different applicants. The average 510(k) review took 133 days (median 84).
Definition
These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.
Classification
| Field | Value |
|---|---|
| Device name | Vessel Guard Or Cover |
| Device class | Class II |
| Regulation | 21 CFR 870.3470 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OMR clearance
Top OMR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mimedx Group, Inc. | 4 | 2011-05-20 |
| Synthes Spine | 2 | 2012-06-14 |
| Spinemedica, LLC | 2 | 2009-12-24 |
| Xylos Corporation | 1 | 2010-07-07 |
| Replication Medical, Inc. | 1 | 2009-04-02 |
Most recent OMR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111048 | Synthes Spine | SYNTHES SCOUT TACK FIXATION | 2012-06-14 | 426 |
| K111137 | Mimedx Group, Inc. | HYDROFIX VASO SHIELD | 2011-05-20 | 28 |
| K101805 | Mimedx Group, Inc. | HYDROFIX VASO SHIELD | 2011-04-08 | 284 |
| K103558 | Synthes Spine | SYNTHES SCOUT VESSEL GUARD | 2011-02-18 | 78 |
| K101826 | Mimedx Group, Inc. | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | 2010-07-28 | 27 |
Recalls for OMR devices
openFDA lists no recalls for product code OMR.
Frequently asked questions
What is FDA product code OMR?
OMR is the FDA product code for vessel guard or cover. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel.
What device class is OMR?
Class II, regulation 21 CFR 870.3470. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMR?
Across 10 cleared submissions the average was 133 days from receipt to decision (median 84).
Which companies have the most OMR clearances?
Mimedx Group, Inc. (4); Synthes Spine (2); Spinemedica, LLC (2); Xylos Corporation (1); Replication Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMR
- Run a recall and safety report across every OMR manufacturer
- Watch product code OMR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times