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)
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.

View all Beijing Honghugaoxiang Science and Technology Development CO devices

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
87d slower than avg
Panel avg: 148d · 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

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
SCALPFIX CLIP SYSTEM
K012219 · Aesculap, Inc. · Jul 2001
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433 · Codman & Shurtleff, Inc. · Feb 1991
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
K894778 · Codman & Shurtleff, Inc. · Dec 1989
RANEY AND LEROY-RANEY SCALP CLIP
K883963 · New England Surgical Instrument Corp. · Oct 1988
RANEY CLIPS
K881265 · Zimmer, Inc. · May 1988