Cleared Traditional

K011861 - BERNOULLI VENTILATOR MANAGEMENT SYSTEM

K011861 is an FDA 510(k) clearance for BERNOULLI VENTILATOR MANAGEMENT SYSTEM, manufactured by Cardiopulmonary Corp.. The device is a Class 2 Anesthesiology device with product code MOD cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K011861 · Cardiopulmonary Corp. · Anesthesiology device
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Nov 2001
Decision
145d
Days
Class 2
Risk

K011861 is an FDA 510(k) clearance for the BERNOULLI VENTILATOR MANAGEMENT SYSTEM. Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by Cardiopulmonary Corp. (Milford, US). The FDA issued a Cleared decision on November 6, 2001 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K011861

510(k) Number K011861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date November 06, 2001
Days to Decision 145 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 140d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOD Device Classification - Class 2, Special Controls

Product Code MOD Accessory To Continuous Ventilator (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MOD Accessory To Continuous Ventilator (respirator)

All 15
Devices cleared under the same product code (MOD) and FDA review panel - the closest regulatory comparables to K011861.
AIR SAFETY HEPA, MODEL 3500
K040712 · Air Safety, Ltd. · Jun 2004
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062 · Impact Instrumentation, Inc. · May 2003
TRI-PLEX ADAPTER
K010401 · The Medical Device Group, Inc. · Oct 2002
VENTNET
K963633 · Puritan Bennett Corp. · Dec 1996
BICORE SMARTCATH INTRATRACHEAL CATHETER
K935788 · Bicore Monitoring Systems · Jul 1995
VENTILATION MECHANICS MONITOR MODEL VMM-100
K936156 · Smith Industries Medical Systems (Sims) · Jun 1995