Cleared Traditional

K983219 - NEOFLOW OPTION MODEL NUMBERS 8413563

K983219 is an FDA 510(k) clearance for NEOFLOW OPTION MODEL NUMBERS 8413563, manufactured by Drager, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K983219 · Drager, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
84d
Days
Class 2
Risk

K983219 is an FDA 510(k) clearance for the NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Drager, Inc. (Telford, US). The FDA issued a Cleared decision on December 7, 1998 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Drager, Inc. devices

FDA 510(k) Submission Details - K983219

510(k) Number K983219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date December 07, 1998
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
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 318
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K983219.
DRAGER OXYLOG 2000
K984577 · Drager, Inc. · Jan 1999
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · Puritan Bennett Corp. · Dec 1998
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · Puritan Bennett Corp. · Dec 1998
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
K983981 · Bear Medical Systems, Inc. · Nov 1998
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998
BIRD MONITOR INTERFACE
K982580 · Bird Products Corp. · Oct 1998