510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082829Substantially Equivalent

Aircraft Medical Oxygen Generation System (Amogs)

Mission Systems Davenport Inc., Davenport IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082829 is the FDA 510(k) clearance record for AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS), a class II device, cleared for Carleton Life Support Systems, Inc. on under FDA product code OLF (Medevac Use Oxygen Generator). FDA's definition for product code OLF reads: "A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and...". FDA records list 3 510(k) clearances for Mission Systems Davenport Inc., from to . As of , FDA records show one recall naming K082829.

Clearance record

Decision date
Received
(88 days to decision)
Product code
OLF Medevac Use Oxygen Generator
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Carleton Life Support Systems, Inc. 2734 Hickory Grove Rd., Davenport IA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLF

Trailing 12 months

FDA records hold no clearances under product code OLF in the trailing twelve months.

FDA records show no clearances under product code OLF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OLF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260