Cleared Traditional

K262229 - DORO® Headrest System for AVA

K262229 is an FDA 510(k) clearance for DORO Headrest System for AVA, manufactured by Black Forest Medical GmbH. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K262229 · Black Forest Medical GmbH · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
119d
Days
Class 2
Risk

K262229 is an FDA 510(k) clearance for the DORO® Headrest System for AVA. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Black Forest Medical GmbH (Freiburg, DE). The FDA issued a Cleared decision on October 27, 2026 after a review of 119 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.

FDA 510(k) Submission Details - K262229

510(k) Number K262229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2026
Decision Date October 27, 2026
Days to Decision 119 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
30d faster than avg
Panel avg: 149d · This submission: 119d
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 50
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K262229 · DORO® Headrest System for AVA
Download PDF FDA Summary Black Forest Medical …