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

Goleta, CA, US

INOGEN, INC. appears in FDA device records in Goleta, CA. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. 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
2

510(k) clearance history

FDA records hold 5 510(k) clearances for Inogen, Inc between 2004 and 2024. The busiest year on record is 2004, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Inogen, Inc, by decision year
YearClearances
20041
20141
20221
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241091SIMEOX 200 Airway Clearance DeviceSDTSubstantially Equivalent
K230052Inogen Rove 6CAWSubstantially Equivalent
K222086Inogen Rove 4 Portable Oxygen ConcentratorCAWSubstantially Equivalent
K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAWSubstantially Equivalent
K032818INOGEN ONE OXYGEN CONCENTRATORCAWSubstantially Equivalent

Registered establishments

FDA registered establishments for Inogen, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30046722753004672275INOGEN, INC.859 Ward Drive, Goleta, CA 93111 US2026
30193857423009843463Inogen, Inc600 Shiloh Rd., Plano, TX 75074 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-1368-05Portable Oxygen GeneratorFirm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.Terminated

Verification record

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