Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006182632

FEI Number

3006182632

Entity Name

CIRCADIANCE

City/State/Country

Export, PA, US

Establishment Address

1010 Corporate Lane, Export, PA 15632, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Circadiance (Owner Number: 10028090)

Owner / Operator Contact Address

1010 Corporate Lane, Export, PA 15632, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011597

PMA Number

N/A

All Registered Proprietary Names

SleepWeaver Nasal CPAP Mask SleepWeaver Anew Full Face Soft Cloth PAP Mask SmartMonitor 2PS SleepWeaver Advance Pediatric Nasal CPAP Mask SleepWeaver FeatherWeight Tube SleepWeaver ELAN Nasal CPAP Mask SleepWeaver 3D Nasal Mask SmartMonitor 2 Professional Series (PS) SmartMonitor 2 / Synergy-E

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2009-12-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-07-12
NPF	Monitor, Apnea, Home Use	Anesthesiology	Class 2	868.2377	2015-07-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-07-15
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-06-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2008-12-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-12-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2017-03-22
NPF	Monitor, Apnea, Home Use	Anesthesiology	Class 2	868.2377	2015-07-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-07-15
FLS	Monitor, Apnea, Facility Use	Anesthesiology	Class 2	868.2377	2015-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Circadiance

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651

Similar Registrations

Registration Number	Establishment Name	Location
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
3013505405	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN
3033530343	BMC INVESTMENT HOLDING LIMITED	Hong Kong, HK
3017684630	ResMed Asia Pte. Ltd.	Singapore South West, SG
3042507287	3B MEDICAL INC	W Jefferson, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006182632. Last updated year: 2026. Please use registration number 3006182632 when referencing this establishment in official correspondence.