Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030745

FEI Number

3000204983

Entity Name

SPIRACLE TECHNOLOGY

City/State/Country

Los Alamitos, CA, US

Establishment Address

10601 Calle Lee Ste 190, Los Alamitos, CA 90720, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPIRACLE TECHNOLOGY (Owner Number: 9026347)

Owner / Operator Contact Address

10601 Calle Lee, Ste 190, --, Los Alamitos, CA 90720, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K953349

PMA Number

N/A

All Registered Proprietary Names

FERNO2 CPR MASK FERNO2 FERNO2 ORO2 REGULATOR BravO2 Regulator ORO2 FLOW CONTROL VALVE 302 OX Inhaltor OX Inhalator FERNO2 MVP FERNO2 PEZO2 FERNO2 HFOC Gaseous Oxygen Supply Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2009-03-06
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2023-05-26
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2010-11-17
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	1996-06-06
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	1996-06-06
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-11-02
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2009-03-06
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2009-03-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-12-04
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-11-02

Official Correspondent

MICHAEL SARNE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPIRACLE TECHNOLOGY

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
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030745. Last updated year: 2026. Please use registration number 2030745 when referencing this establishment in official correspondence.