510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921809Substantially Equivalent

Companion 800 Portable Nebulizer Compressor (C800)

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

K921809 is the FDA 510(k) clearance record for COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800), a class II device, cleared for Puritan Bennett Corp. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K921809.

Clearance record

Decision date
Received
(233 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 9401 Indian Creek Pkwy., Overland Park KS
510(k) summary
Statement
Third party review
No

Clearances, product code CAF

Trailing 12 months
3 clearances under product code CAF in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260