Data / Medical devices / United States / Omarc LLC
Omarc LLC: FDA-registered device maker in Norwood, MA, United States, 2 510(k) clearances
Omarc LLC is registered with the FDA (registration 3004036118) in Norwood, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 13, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004036118
- Address
- 588 Pleasant Street Suite 2, Norwood, MA, United States, 02062
- Owner or operator
- NEOGENIX, LLC dba OGENIX (9053370)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 20, 2015
- Registered through
- 2026
- Brand names listed
- EPIFLO, EPIFLO-28
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Oxygen, Topical, Extremity | KPJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2019 | K190742 | EPIFLO-28 | KPJ | Substantially Equivalent | Neogenix, LLC Dba Ogenix | accessdata.fda.gov |
| April 27, 2012 | K120764 | EPIFLO(R) | KPJ | Substantially Equivalent | Neogenix, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 16, 2012 | 61635 | Not yet classified | Terminated | EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO Sys | Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date. | accessdata.fda.gov |
| March 24, 2006 | 36130 | Not yet classified | Terminated | Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFL | Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution. | accessdata.fda.gov |
Compare with other makers
Updated December 13, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.