510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800931Substantially Equivalent

R2(tm) ECG Cable-Adaptor #'S 120-121-122

R2 Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800931 is the FDA 510(k) clearance record for R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122, a class II device, cleared for R2 Corp. on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 7 510(k) clearances for R2 Corp., from to . As of , FDA records show no recalls naming K800931.

Clearance record

Decision date
Received
(32 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
R2 Corp. 803 N. Front St. Suite 3, Mchenry IL
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