Cleared Traditional

DORO LUCENT Skull Clamp (1101.001) (K240319) - FDA 510(k) Clearance

Also marketed or referenced as:
DORO LUCENT Skull Clamp Pediatric Set (1101.040)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240319 · Pro-Med Instruments GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
82d
Days
Class 2
Risk

K240319 is an FDA 510(k) clearance for the DORO LUCENT Skull Clamp (1101.001). 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 April 24, 2024 after a review of 82 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

Submission Details

510(k) Number K240319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date April 24, 2024
Days to Decision 82 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
66d faster than avg
Panel avg: 148d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K240319.
mb-FIX Cranial Stabilization Systems
K250423 · Medical Bees GmbH · Nov 2025
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)
K241883 · Pro-Med Instruments GmbH · Jul 2024
DORO QR3 Headrest System (Aluminum)
K203505 · Pro-Med Instruments GmbH · Mar 2021
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
K193438 · Pro-Med Instruments GmbH · Jun 2020
DORO LUCENT® iXI and iMRI Headrest System
K191740 · Pro-Med Instruments GmbH · Feb 2020
Arcus Head Fixation Frame
K191701 · Mri Interventions, Inc. · Nov 2019