MEDIPINES CORPORATION

FDA Device Registration & Listing · Yorba Linda, CA, US · Registration 3015272694

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015272694
FEI Number
3015272694
Entity Name
MEDIPINES CORPORATION
City/State/Country
Yorba Linda, CA, US
Establishment Address
22755 Savi Ranch Pkwy Ste C, Yorba Linda, CA 92887, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
MediPines Corporation (Owner Number: 10059619)
Owner / Operator Contact Address
22755 Savi Ranch Pkwy Ste C, Yorba Linda, CA 92887, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180902
PMA Number
N/A

All Registered Proprietary Names

MediPines Gas Exchange Monitor AGM100

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2019-02-04
DQA Oximeter Cardiovascular Class 2 870.2700 2019-02-04
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2019-02-04
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2019-02-04

Official Correspondent

Matthew Osburn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MediPines Corporation
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
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
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-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015272694. Last updated year: 2026. Please use registration number 3015272694 when referencing this establishment in official correspondence.
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