510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K973468Substantially Equivalent

Model Irc 1199 Scout Nebulizer

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973468 is the FDA 510(k) clearance record for MODEL IRC 1199 SCOUT NEBULIZER, a class II device, cleared for Invacare Corp. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K973468.

Clearance record

Decision date
Received
(87 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Invacare Corp. 899 Cleveland St., Elyria OH
510(k) summary
Summary
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