Cleared Traditional

K253814 - Raney Clips Kit

K253814 is an FDA 510(k) clearance for Raney Clips Kit, manufactured by Beijing Honghugaoxiang Science and Technology Development CO. The device is a Class 2 Neurology device with product code HBO cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K253814 · Beijing Honghugaoxiang Science and Technology Development CO · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
235d
Days
Class 2
Risk

K253814 is an FDA 510(k) clearance for the Raney Clips Kit. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Beijing Honghugaoxiang Science and Technology Development CO (Beijing, CN). The FDA issued a Cleared decision on July 21, 2026 after a review of 235 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4150 - 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 - K253814

510(k) Number K253814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date July 21, 2026
Days to Decision 235 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
86d slower than avg
Panel avg: 149d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBO Device Classification - Class 2, Special Controls

Product Code HBO Clip, Scalp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4150
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 - HBO Clip, Scalp

All 10
Devices cleared under the same product code (HBO) and FDA review panel - the closest regulatory comparables to K253814.
MEDTRONIC CLIP GUN KIT
K050044 · Medtronic Neurosurgery · Feb 2005
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
K033660 · Rudolf Storz GmbH · Jan 2004
SCALPFIX CLIP SYSTEM
K012219 · Aesculap, Inc. · Jul 2001
ACRA-CUT
K944311 · Acra Cut, Inc. · Nov 1994
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433 · Codman & Shurtleff, Inc. · Feb 1991
CLIP GUN WITH RANEY TYPE SCALP CLIPS
K896723 · Omni Medical Designs · Mar 1990
K253814 · Raney Clips Kit
Download PDF FDA Summary Beijing Honghugaoxian…