510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070710Substantially Equivalent

Accutrans Disposable Pressure Monitoring System

Biosensors International-USA, Newport Beach CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070710 is the FDA 510(k) clearance record for ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM, a class II device, cleared for Biosensors International-USA on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 2 510(k) clearances for Biosensors International-USA, from to . As of , FDA records show no recalls naming K070710.

Clearance record

Decision date
Received
(36 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosensors International-USA 20280 Acacia St., Suite 300, Newport Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRS

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