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

Chicago, IL, US

Coapt LLC appears in FDA device records in Chicago, IL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls 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
2
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Coapt LLC between 2017 and 2023. The busiest year on record is 2019, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Coapt LLC, by decision year
YearClearances
20171
20192
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223738Alpha Control Liner System (ACLS)GXYSubstantially Equivalent
K223605ControlSeal Electrode (ELSB)GXYSubstantially Equivalent
K191083COMPLETE CONTROL System Gen2GXYSubstantially Equivalent
K190416Dome ElectrodeGXYSubstantially Equivalent
K162891Complete Control SystemGXYSubstantially Equivalent

Registered establishments

FDA registered establishments for Coapt LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30106058763010605876Coapt LLC303 W. Institute Pl., Chicago, IL 60610 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-0204-2024Coapt ControlSeal Electrode, cutaneous EMG ElectrodePatient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.Class IIOpen, Classified
Z-0203-2024Coapt Dome Electrode, Gen2 system, cutaneous electrodePatient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.Class IIOpen, Classified

Verification record

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