510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K151246Substantially Equivalent

Aneroid Sphygmomanometer

Jiaxing Zhongfa Medical Products Co., Ltd., Jiaxing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151246 is the FDA 510(k) clearance record for Aneroid Sphygmomanometer, a class II device, cleared for Jiaxing Zhongfa Medical Products Co., Ltd. on under FDA product code DXQ (Blood Pressure Cuff). FDA's definition for product code DXQ reads: "A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure". FDA records list one 510(k) clearance for Jiaxing Zhongfa Medical Products Co., Ltd. As of , FDA records show no recalls naming K151246.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DXQ Blood Pressure Cuff
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Applicant
Jiaxing Zhongfa Medical Products Co., Ltd. #38 Bldg. 1, Zhong Fa Group, Jiaxing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXQ

Trailing 12 months
5 clearances under product code DXQ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260