Cleared Traditional

K254177 - Disposable Sterile Skull Drill (LZ)

K254177 is an FDA 510(k) clearance for Disposable Sterile Skull Drill (LZ), manufactured by Guizhou Zirui Technology Co., Ltd.. The device is a Class 2 Neurology device with product code HBF cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K254177 · Guizhou Zirui Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
262d
Days
Class 2
Risk

K254177 is an FDA 510(k) clearance for the Disposable Sterile Skull Drill (LZ). Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Guizhou Zirui Technology Co., Ltd. (Zunyi, CN). The FDA issued a Cleared decision on September 11, 2026 after a review of 262 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4305 - 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 Guizhou Zirui Technology Co., Ltd. devices

FDA 510(k) Submission Details - K254177

510(k) Number K254177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date September 11, 2026
Days to Decision 262 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
113d slower than avg
Panel avg: 149d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBF Device Classification - Class 2, Special Controls

Product Code HBF Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4305
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 Consultant

Nanos Medical Shanghai Limited
Yoyo Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HBF Drills, Burrs, Trephines & Accessories (compound, Powered)

All 14
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K254177.
evoDrill Cranial Perforator
K231403 · Evonos GmbH & Co. KG · Mar 2024
NeuroLine Disposable Cranial Perforator with Hudson end
K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · Jun 2022
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp. · Jan 2019
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455 · Micromar Ind. Com. , Ltd. · Mar 2015
MERIDIAN CRANIAL PERFORATOR
K121253 · Adeor Medical Technologies GmbH · Jul 2012
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K082010 · Stryker Ireland Ltd., Instruments Division · Dec 2008