510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K081267Substantially Equivalent

Hygeia-5 Oxygen Concentrator

Kedl Internation Limited, Fort Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081267 is the FDA 510(k) clearance record for HYGEIA-5 OXYGEN CONCENTRATOR, a class II device, cleared for Kedl Internation Limited on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Kedl Internation Limited. As of , FDA records show no recalls naming K081267.

Clearance record

Decision date
Received
(141 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Kedl Internation Limited 7690 Cameron Cir., Fort Myers FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260