Cleared Abbreviated

K984611 - DRAGER SOLA SERIES, MODELS 1000/700/500/300

K984611 is an FDA 510(k) clearance for DRAGER SOLA SERIES, manufactured by Drager Medizintechnik GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K984611 · Drager Medizintechnik GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
90d
Days
Class 2
Risk

K984611 is an FDA 510(k) clearance for the DRAGER SOLA SERIES, MODELS 1000/700/500/300. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Drager Medizintechnik GmbH (Lubeck, DE). The FDA issued a Cleared decision on March 29, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Drager Medizintechnik GmbH devices

FDA 510(k) Submission Details - K984611

510(k) Number K984611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1998
Decision Date March 29, 1999
Days to Decision 90 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 46
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K984611.
MILLENNIUM GOLD
K992090 · Skytron, Div. the Kmw Group, Inc. · Sep 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · Berchtold Holding GmbH · Jul 1999
CHROMOPHARE D500, D530, D650
K991527 · Berchtold Holding GmbH · May 1999
ALM PRISMALIX (PRX) SURGICAL LIGHT
K982063 · Alm Surgical Equipment, Inc. · Sep 1998
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
K974084 · Getinge/Castle, Inc. · Mar 1998