510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100310Substantially Equivalent

Btl-08 ECG Recorder Model Btl-08 ECG Lc Plus, Btl-08 ECG Lt Plus

BTL Industries, Inc, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100310 is the FDA 510(k) clearance record for BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS, a class II device, cleared for BTL Industries, Inc. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list 45 510(k) clearances for BTL Industries, Inc., from to . As of , FDA records show no recalls naming K100310.

Clearance record

Decision date
Received
(252 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
BTL Industries, Inc. 1705 S. Capital Of Texas Hwy.,, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWJ

Trailing 12 months
5 clearances under product code MWJ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20261
September 20262
October 20260