510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911143Substantially Equivalent

Pb100 Diagnostic Spirometer

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

K911143 is the FDA 510(k) clearance record for PB100 DIAGNOSTIC SPIROMETER, a class II device, cleared for Puritan Bennett Corp. on under FDA product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K911143.

Clearance record

Decision date
Received
(260 days to decision)
Product code
BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 9401 Indian Creek Pkwy., Overland Park KS
Third party review
No

Clearances, product code BZM

Trailing 12 months

FDA records hold no clearances under product code BZM in the trailing twelve months.

FDA records show no clearances under product code BZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260