510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091028Substantially Equivalent

Omni 5 Total O2 Delivery System

Respironics, Inc., Murrysville PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091028 is the FDA 510(k) clearance record for OMNI 5 TOTAL O2 DELIVERY SYSTEM, a class II device, cleared for Respironics, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K091028.

Clearance record

Decision date
Received
(104 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAW

Trailing 12 months
11 clearances under product code CAW in the twelve months to November 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260
November 20260