Moldex/Metric, Inc.

Culver City, CA, US

MOLDEX/METRIC, INC. appears in FDA device records in Culver City, CA. FDA records list 7 510(k) clearances between 2004-09-30 and 2010-09-13, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 7
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Moldex/Metric, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Inovel, LLC510(k), recall

510(k) clearance history

FDA records hold 7 510(k) clearances for Moldex/Metric, Inc. between 2004 and 2010. The busiest year on record is 2006, with 3. The most recent is 2010, with 1.

Clearances by year, as a table

510(k) clearance decisions for Moldex/Metric, Inc., by decision year
Year	Clearances
2004	1
2005	1
2006	3
2007	1
2010	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K102173	MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712	MSH	Substantially Equivalent	2010-09-13
K063747	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A	MSH	Substantially Equivalent	2007-01-12
K062665	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS	MSH	Substantially Equivalent	2006-10-24
K062663	MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS	MSH	Substantially Equivalent	2006-10-11
K061859	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS	MSH	Substantially Equivalent	2006-07-12
K051182	INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS	MSH	Substantially Equivalent	2005-05-19
K042267	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP	MSH	Substantially Equivalent	2004-09-30

Registered establishments

FDA registered establishments for Moldex/Metric, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2023299	1000098753	MOLDEX/METRIC, INC.	10111 Jefferson Blvd, CULVER CITY, CA 90232 US	2026	MSH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

MSHRespirator, Surgical

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1576-2009	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.		2008-07-23	Terminated
Z-0587-06	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		2006-02-20	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain