510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980441Substantially Equivalent

Spirometer Model Npb-500

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

K980441 is the FDA 510(k) clearance record for SPIROMETER MODEL NPB-500, a class II device, cleared for Nellcor Puritan Bennett, Inc. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K980441.

Clearance record

Decision date
Received
(85 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
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 BZG

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