Cleared Traditional

K001808 - DORO HEADREST SYSTEM

K001808 is an FDA 510(k) clearance for DORO HEADREST 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 50-day FDA review.

K001808 · Pro-Med Instruments GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
50d
Days
Class 2
Risk

K001808 is an FDA 510(k) clearance for the DORO HEADREST SYSTEM. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Pro-Med Instruments GmbH (Roswell, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 50 days - a notably fast clearance cycle.

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: 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 Pro-Med Instruments GmbH devices

FDA 510(k) Submission Details - K001808

510(k) Number K001808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2000
Decision Date August 04, 2000
Days to Decision 50 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
99d faster than avg
Panel avg: 149d · This submission: 50d
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 45
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K001808.
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MIZUHO RADIOLUCENT HEAD FRAME
K955012 · Mizuho America, Inc. · Sep 1996
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
K953124 · Ohio Medical Instrument Co., Inc. · Feb 1996
MAYFIELD CHILD DISPOSABLE SKULL PIN
K941558 · Ohio Medical Instrument Co., Inc. · Dec 1995