510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250671Substantially Equivalent

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Caire, Inc., Ball Ground GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250671 is the FDA 510(k) clearance record for FreeStyle Comfort (AS200 / FreeStyle Comfort), a class II device, cleared for Caire, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list 2 510(k) clearances for Caire, Inc., from to . As of , FDA records show no recalls naming K250671.

Clearance record

Decision date
Received
(128 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Caire, Inc. 2200 Airport Industrial Dr., Suite 500, Ball Ground GA
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