510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K980806Substantially Equivalent

Affinity Medical Patient Cable System

Affinity Medical Technologies, LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980806 is the FDA 510(k) clearance record for AFFINITY MEDICAL PATIENT CABLE SYSTEM, a class II device, cleared for Affinity Medical Technologies, LLC on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list one 510(k) clearance for Affinity Medical Technologies, LLC. As of , FDA records show no recalls naming K980806.

Clearance record

Decision date
Received
(22 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
Affinity Medical Technologies, LLC 17332 Von Karman Ave., #115, Irvine 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