Cleared Traditional

K010093 - NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

K010093 is an FDA 510(k) clearance for NON-INVASIVE VENTILATION NIV OPTION, manufactured by Drager Medizintechnik GmbH. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K010093 · Drager Medizintechnik GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
154d
Days
Class 2
Risk

K010093 is an FDA 510(k) clearance for the NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Drager Medizintechnik GmbH (Telford, US). The FDA issued a Cleared decision on June 14, 2001 after a review of 154 days - an extended review cycle.

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 - K010093

510(k) Number K010093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date June 14, 2001
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 488
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K010093.
AV 800 VENTILATOR
K010317 · Penlon , Ltd. · Jul 2001
IVENT 201 PORTABLE VENTILATOR
K011957 · Versamed , Ltd. · Jul 2001
SAVINA
K003068 · Drager Medizintechnik GmbH · Jun 2001
MODIFICATION TO LAP TOP VENTILATOR (LTV)
K010608 · Pulmonetic Systems, Inc. · Mar 2001
BIRD TBIRD LEGACY VENTILATOR
K003770 · Bird Products Corp. · Dec 2000
MAGELLAN VENTILATOR
K002951 · Oceanic Medical Products, Inc. · Dec 2000
K010093 · NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
Download PDF FDA Summary Drager Medizintechnik…