510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K111933Substantially Equivalent

Covidien Nellcor Respiration Rate Software Application, Version 1.0

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111933 is the FDA 510(k) clearance record for COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0, a class II device, cleared for Covidien on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K111933.

Clearance record

Decision date
Received
(251 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Covidien 6135 Gunbarrel Ave., Boulder CO
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 November 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260
November 20260