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Circadiance: FDA-registered device maker in Export, PA, United States, 9 510(k) clearances

Name: Circadiance FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Circadiance is registered with the FDA (registration 3006182632) in Export, PA, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 15, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006182632
Address: 1010 Corporate Lane, Export, PA, United States, 15632
Owner or operator: Circadiance (10028090)
Roles: Specification developer
First device listed: December 29, 2008
Registered through: 2026
Brand names listed: NepPAP System, SleepWeaver 3D Nasal Mask, SleepWeaver Advance Pediatric Nasal CPAP Mask, SleepWeaver Anew Full Face Soft Cloth PAP Mask, SleepWeaver ELAN Nasal CPAP Mask, SleepWeaver FeatherWeight Tube, SleepWeaver Nasal CPAP Mask, SmartMonitor 2 / Synergy-E and more

Devices it lists

Device	Product code	Class	Role	Source
Mask, Oxygen	BYG	1	Specification developer	accessdata.fda.gov
Monitor, Apnea, Facility Use	FLS	2	Specification developer	accessdata.fda.gov
Monitor, Apnea, Home Use	NPF	2	Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Specification developer	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 15, 2017	K162905	SleepWeaver 3D Nasal Mask	BZD	Substantially Equivalent	Circadiance, LLC	accessdata.fda.gov
April 5, 2016	K151683	SleepWeaver Advance Pediatric Nasal CPAP Mask	BZD	Substantially Equivalent	Circadiance, LLC	accessdata.fda.gov
May 24, 2013	K130481	SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK	BZD	Substantially Equivalent	Circadiance, LLC	accessdata.fda.gov
April 24, 2012	K120757	SLEEPWEAVER ELAN NASAL CPAP MASK	BZD	Substantially Equivalent	Circadiance, LLC	accessdata.fda.gov
March 30, 2011	K103410	NEOPAP SYSTEM	BZD	Substantially Equivalent	Childrens Medical Ventures, LLC	accessdata.fda.gov
November 2, 2009	K092362	SLEEPWEAVER NASAL CPAP MASK	BZD	Substantially Equivalent	Circadiance, LLC	accessdata.fda.gov
August 2, 2006	K061256	SMARTMONITOR 2PS	NPF	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 27, 2003	K032403	SMARTMONITOR 2 PROFESSIONAL SERIES (PS)	NPF	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
January 11, 2002	K011597	SMARTMONITOR 2, MODEL 4000	FLS	Substantially Equivalent	Respironics Georgia, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 1, 2017	77176	Class II	Terminated	SmartMonitor 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.	accessdata.fda.gov

Compare with other makers

Updated March 15, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.