510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101660Substantially Equivalent

ECG Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8

Kepler Medtec, Ashland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101660 is the FDA 510(k) clearance record for ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8, a class II device, cleared for Kepler Medtec on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 2 510(k) clearances for Kepler Medtec, from to . As of , FDA records show no recalls naming K101660.

Clearance record

Decision date
Received
(58 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
Kepler Medtec 200 Homer Ave., Ashland MA
510(k) summary
Summary PDF
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