510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K010809Substantially Equivalent

Bioconnect Patient Monitoring Cables and Leadwires, Cat# 1000 Thru Cat# 40000

Rf Industries, Ltd., Lake Elsinore CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010809 is the FDA 510(k) clearance record for BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000, a class II device, cleared for Rf Industries, Ltd. on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list one 510(k) clearance for Rf Industries, Ltd. As of , FDA records show no recalls naming K010809.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
Rf Industries, Ltd. 541-A Birch St., Lake Elsinore CA
510(k) summary
Summary
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA 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 DSA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260