Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013116677

FEI Number

3013116677

Entity Name

PROSOMNUS SLEEP TECHNOLOGIES

City/State/Country

Pleasanton, CA, US

Establishment Address

5675 Gibraltar Drive, Pleasanton, CA 94588, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ProSomnus Sleep Technologies (Owner Number: 10053490)

Owner / Operator Contact Address

5675 Gibraltar Drive, Pleasanton, CA 94588, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161624

PMA Number

N/A

All Registered Proprietary Names

ProSomnus HWO2 Device Prosomnus CA Sleep and Snore Device Prosomnus CA Sleep and snore Device with Compliance Monitoring Prosomnus [PH] Sleep and Snore Device Prosomnus [CA] Low Profile Sleep and snore Device with Compliance Monitoring Prosomnus [PH] Sleep and Snore Device with Compliance Monitoring MicrO2 Sleep Device Prosomnus [IA] Sleep Device ProSomnus® EVO [PH] Sleep and Snore Device ProSomnus® EVO [PH] Sleep and Snore Device with Patient Monitoring ProSomnus RPMO2 OSA Device ProSomnus® EVO Sleep and Snore Device ProSomnus® EVO Sleep and Snore Device with Patient Monitoring MicrO2 Sleep Device with MicroRecorder Prosomnus [IA] Sleep Device with MicroRecorder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2025-07-29
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2017-12-03
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-12-03
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2016-12-09
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2022-10-10
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2026-04-21
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2026-04-21
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2026-04-21
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2026-04-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-21
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2020-11-23
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2020-11-23
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2020-11-23
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2016-12-09

Official Correspondent

Divya Mavalli

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ProSomnus Sleep Technologies

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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
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
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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3007858728	Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd	Shenzhen Guangdong, CN
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013116677. Last updated year: 2026. Please use registration number 3013116677 when referencing this establishment in official correspondence.