510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243183Substantially Equivalent

RTMsense Respiratory Monitoring System

Rtm Vital Signs, LLC, Ambler PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243183 is the FDA 510(k) clearance record for RTMsense Respiratory Monitoring System, a class II device, cleared for Rtm Vital Signs, LLC on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list one 510(k) clearance for Rtm Vital Signs, LLC. As of , FDA records show no recalls naming K243183.

Clearance record

Decision date
Received
(270 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Rtm Vital Signs, LLC 8 Richards Way, Ambler PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ 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 BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260