Cleared Traditional

K232842 - Balloon Inflation System (FDA 510(k) Clearance)

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

K232842 · Ningbo Hicren Biotechnology Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
168d
Days
Class 2
Risk

K232842 is an FDA 510(k) clearance for the Balloon Inflation System. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Ningbo Hicren Biotechnology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on February 29, 2024 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ningbo Hicren Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K232842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2023
Decision Date February 29, 2024
Days to Decision 168 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 Orthopedic devices follow this clearance model.

Regulatory Consultant

Pureid Medical Technology Co., Ltd.
Raymond Wu

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 - NDN Cement, Bone, Vertebroplasty

All 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K232842.
XeliteMed SuperM-Fix Spinal Bone Cement
K251896 · Xelite Biomed , Ltd. · Jan 2026
VCFix Spinal System
K250637 · Amber Implants · May 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
K243537 · Xelite Biomed , Ltd. · Apr 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
K241775 · Xelite Biomed , Ltd. · Sep 2024
V-STRUT® Vertebral Implant
K240084 · Hyprevention · Feb 2024
Renova Spine Balloon Catheter
K231340 · Biopsybell S.R.L. · Oct 2023