510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K111148Substantially Equivalent

S8 Aspen with H4i Plus

ResMed Corp, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111148 is the FDA 510(k) clearance record for S8 ASPEN WITH H4I PLUS, a class II device, cleared for Resmed Corp on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 123 510(k) clearances for Resmed Corp, from to . As of , FDA records show no recalls naming K111148.

Clearance record

Decision date
Received
(69 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Resmed Corp 9001 Spectrum Center Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZD

Trailing 12 months
12 clearances under product code BZD in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20261
November 20260