Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005160810

FEI Number

3005160810

Entity Name

MERLYN ASSOCIATES, INC.

City/State/Country

Santa Ana, CA, US

Establishment Address

2850 South Harbor Blvd., Santa Ana, CA 92704, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MERLYN ASSOCIATES, INC. (Owner Number: 9071259)

Owner / Operator Contact Address

2850 South Harbor Blvd., --, Santa Ana, CA 92704, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042683

PMA Number

N/A

All Registered Proprietary Names

Disposable Air Cushion Face Mask Oxygen Mask Merlyn Reservoir Merlyn Wound Drain ENDOMASK ESSENTIAL ENDOMASK ECLIPSE ENDOMASK ELITE ENDOTUBE ENDOTRACHEAL TUBES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2024-12-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2024-12-27
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2020-12-25
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2006-05-04
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2005-03-11

Official Correspondent

Neeka Delaney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERLYN ASSOCIATES, INC.

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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Similar Registrations

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3010362947	Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, CN
2028807	WESTMED, INC.	TUCSON, AZ, US
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3005977696	MEDICAL DEVELOPMENTS INTERNATIONAL	Scoresby Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005160810. Last updated year: 2026. Please use registration number 3005160810 when referencing this establishment in official correspondence.