Cleared Traditional

K093886 - ENGSTROM CARESTATION, ENGSTROM PRO

K093886 is an FDA 510(k) clearance for ENGSTROM CARESTATION, manufactured by Datex-Ohmeda Inc., A Division of Instrumentarium C. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K093886 · Datex-Ohmeda Inc., A Division of Instrumentarium C · Anesthesiology device
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May 2010
Decision
136d
Days
Class 2
Risk

K093886 is an FDA 510(k) clearance for the ENGSTROM CARESTATION, ENGSTROM PRO. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Datex-Ohmeda Inc., A Division of Instrumentarium C (Madison, US). The FDA issued a Cleared decision on May 3, 2010 after a review of 136 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.

View all Datex-Ohmeda Inc., A Division of Instrumentarium C devices

FDA 510(k) Submission Details - K093886

510(k) Number K093886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date May 03, 2010
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 140d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
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 - CBK Ventilator, Continuous, Facility Use

All 422
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K093886.
FLIGHT 60 VENTILATOR, MODEL F-60
K100753 · Flight Medical , Ltd. · Aug 2010
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
VELA VENTILATOR
K093094 · Cardinal Health 207, Inc. · May 2010
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
K093632 · Drager Medical AG & Co. Kgaa · Apr 2010
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
K093633 · Draegerwerk AG & CO Kgaa · Mar 2010
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
K092847 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Mar 2010