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

Export, PA, US

CIRCADIANCE appears in FDA device records in Export, PA. 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 Circadiance between 2009 and 2017. The busiest year on record is 2009, with 1. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Circadiance, by decision year
YearClearances
20091
20121
20131
20161
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K162905SleepWeaver 3D Nasal MaskBZDSubstantially Equivalent
K151683SleepWeaver Advance Pediatric Nasal CPAP MaskBZDSubstantially Equivalent
K130481SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASKBZDSubstantially Equivalent
K120757SLEEPWEAVER ELAN NASAL CPAP MASKBZDSubstantially Equivalent
K092362SLEEPWEAVER NASAL CPAP MASKBZDSubstantially Equivalent

Registered establishments

FDA registered establishments for Circadiance, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30061826323006182632CIRCADIANCE1010 Corporate Lane, Export, PA 15632 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-2250-2017SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.Class IITerminated

Verification record

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