510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K232842Substantially Equivalent

Balloon Inflation System

Ningbo Hicren Biotechnology Co., Ltd., Ningbo, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232842 is the FDA 510(k) clearance record for Balloon Inflation System, a class II device, cleared for Ningbo Hicren Biotechnology Co., Ltd. on under FDA product code NDN (Cement, Bone, Vertebroplasty). FDA records list one 510(k) clearance for Ningbo Hicren Biotechnology Co., Ltd. As of , FDA records show no recalls naming K232842.

Clearance record

Decision date
Received
(168 days to decision)
Product code
NDN Cement, Bone, Vertebroplasty
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Ningbo Hicren Biotechnology Co., Ltd. Bldg. 1 Block B #777 Binhai 4th Rd. Hangzhou Bay, Ningbo, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDN

Trailing 12 months
1 clearance under product code NDN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260