510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983274Substantially Equivalent

Startrack Infant Graphics Monitor

Medtronic, Inc., Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983274 is the FDA 510(k) clearance record for STARTRACK INFANT GRAPHICS MONITOR, a class II device, cleared for Nellcor Puritan Bennett, Inc. on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K983274.

Clearance record

Decision date
Received
(83 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Nellcor Puritan Bennett, Inc. 11150 Thompson Ave., Lenexa KS
510(k) summary
Summary
Third party review
No

Clearances, product code BZK

Trailing 12 months
1 clearance under product code BZK in the twelve months to November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260