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FDA Product Code

FDA Product Code MOD — Clearance Directory

Device Class
Class II
Assigned Panel
Anesthesiology
21 CFR Citation
868.5895

510(k) Clearances — 16 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K261360 EasyCare Tx 2 Resmed Corp 2026-08-27 Traditional PDF ↗
K253807 Valence InVent Xtend™ (CVG-4101-VXA) Convergence Medical Sciences , Ltd. 2026-08-20 Traditional PDF ↗
K260051 CorVision® (91-205-Z0014) CorVent® Medical, Inc. 2026-05-12 Traditional PDF ↗
K242485 EveryWare Breas Medical AB 2025-05-20 Traditional PDF ↗
K161411 Care Cycle Connect Application Respironics, Inc. 2017-02-17 Traditional PDF ↗
K091461 BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE Cardiopulmonary Corp. 2009-08-14 Traditional PDF ↗
K052751 VENTLINK SYSTEM Mediserve Information Systems, Inc. 2005-12-23 Traditional PDF ↗
K052244 IISIS, VERSION 1.0 Innovision Medical Technologies, LLC 2005-10-13 Traditional PDF ↗
K040712 AIR SAFETY HEPA, MODEL 3500 Air Safety, Ltd. 2004-06-03 Traditional PDF ↗
K022062 IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 Impact Instrumentation, Inc. 2003-05-06 Abbreviated PDF ↗
K010401 TRI-PLEX ADAPTER The Medical Device Group, Inc. 2002-10-30 Traditional PDF ↗
K011861 BERNOULLI VENTILATOR MANAGEMENT SYSTEM Cardiopulmonary Corp. 2001-11-06 Traditional PDF ↗
K963633 VENTNET; CENTRAL MONITORING STATION Puritan Bennett Corp. 1996-12-16 Traditional PDF ↗
K935788 BICORE SMARTCATH INTRATRACHEAL CATHETER Bicore Monitoring Systems 1995-07-03 Traditional PDF ↗
K936156 VENTILATION MECHANICS MONITOR MODEL VMM-100 Smith Industries Medical Systems (Sims) 1995-06-27 Traditional PDF ↗
K940739 NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR Newport Medical Instruments, Inc. 1995-03-07 Traditional PDF ↗

Product code MOD · Class II · Anesthesiology. Data: openFDA.