Cleared Traditional

K191979 - DORO QR3 XTom Headholder System

K191979 is an FDA 510(k) clearance for DORO QR3 XTom Headholder System, manufactured by Pro-Med Instruments GmbH. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K191979 · Pro-Med Instruments GmbH · Neurology device
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Oct 2019
Decision
90d
Days
Class 2
Risk

K191979 is an FDA 510(k) clearance for the DORO QR3 XTom Headholder System. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on October 22, 2019 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pro-Med Instruments GmbH devices

FDA 510(k) Submission Details - K191979

510(k) Number K191979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2019
Decision Date October 22, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 Neurology devices follow this clearance model.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 24
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K191979.
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
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Arcus Head Fixation Frame
K191701 · Mri Interventions, Inc. · Nov 2019
MAYFIELD Skull Clamp
K142238 · Integra LifeSciences Corporation · Nov 2014
STERILE RADIOLUCENT SKULL PINS
K122225 · Brainlab AG · Apr 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389 · Integra LifeSciences Corporation · Apr 2013