Data / Medical devices / United States / Moldex/Metric, Inc.
Moldex/Metric, Inc.: FDA-registered device maker in Culver City, CA, United States, 4 510(k) clearances
Moldex/Metric, Inc. is registered with the FDA (registration 2023299) in Culver City, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 13, 2010. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2023299
- FEI number
- 1000098753
- Address
- 10111 Jefferson Blvd, Culver City, CA, United States, 90232
- Owner or operator
- MOLDEX/METRIC, INC. (2023299)
- Roles
- Manufacturer
- First device listed
- December 13, 2007
- Registered through
- 2027
- Brand names listed
- Airwave 4150, Airwave 4151, Airwave 4650, Airwave 4651, Moldex FASTFIT, Model 1712 N95 Healthcare Particulate, Moldex Health Care N95/Surgical, Moldex N95 Healthcare and Surgical Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Respirator, Surgical | MSH | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 13, 2010 | K102173 | MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 | MSH | Substantially Equivalent | Moldex/Metric, Inc. | accessdata.fda.gov |
| October 24, 2006 | K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | MSH | Substantially Equivalent | Inovel, LLC | accessdata.fda.gov |
| October 11, 2006 | K062663 | MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS | MSH | Substantially Equivalent | Moldex/Metric, Inc. | accessdata.fda.gov |
| July 12, 2006 | K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS | MSH | Substantially Equivalent | Inovel, 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 |
|---|---|---|---|---|---|---|
| July 23, 2008 | 52170 | Not yet classified | Terminated | Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010. | Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators. | accessdata.fda.gov |
| February 20, 2006 | 34658 | Not yet classified | Terminated | Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161. | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2010. 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.