510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nihon Kohden Orangemed, LLC

Santa Ana, CA, US

NIHON KOHDEN ORANGEMED, LLC appears in FDA device records in Santa Ana, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Nihon Kohden Orangemed, LLC between 2018 and 2024. The busiest year on record is 2018, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nihon Kohden Orangemed, LLC, by decision year
YearClearances
20181
20201
20221
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231778Nihon Kohden NKV-550 Series Ventilator SystemCBKSubstantially Equivalent
K222644Nihon Kohden NKV-440 Ventilator SystemCBKSubstantially Equivalent
K213521Nihon Kohden NKV-330 Ventilator SystemMNTSubstantially Equivalent
K192307Nihon Kohden NKV-550 Series Ventilator SystemCBKSubstantially Equivalent
K181695Nihon Kohden NKV-550 Series Ventilator SystemCBKSubstantially Equivalent

Registered establishments

FDA registered establishments for Nihon Kohden Orangemed, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30146312523014631252NIHON KOHDEN ORANGEMED, LLC1800 E. Wilshire Avenue, Santa Ana, CA 92705 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2435-2021Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain