510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003745Substantially Equivalent

Laryngeal Surface Electrode-Endotracheal Tube, M-500-Et, Lse-Et

Rln Systems, Inc., Jefferson City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003745 is the FDA 510(k) clearance record for LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET, a class II device, cleared for Rln Systems, Inc. on under FDA product code ETN (Stimulator, Nerve). FDA records list 5 510(k) clearances for Rln Systems, Inc., from to . As of , FDA records show one recall naming K003745.

Clearance record

Decision date
Received
(43 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Rln Systems, Inc. 2019 Honeysuckle Ln., Jefferson City MO
510(k) summary
Summary
Third party review
No

Clearances, product code ETN

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