510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K022103Substantially Equivalent

Puritan-Bennett 700 Renaissance II Spirometry System

Medtronic, Inc., Carlsbad CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022103 is the FDA 510(k) clearance record for PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM, a class II device, cleared for Puritan Bennett Corp. 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 K022103.

Clearance record

Decision date
Received
(91 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 2200 Faraday Ave., Carlsbad CA
510(k) summary
Summary PDF
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