510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010966Substantially Equivalent

Medley Sp02 Module, Model 8220

CareFusion 303, Inc, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010966 is the FDA 510(k) clearance record for MEDLEY SP02 MODULE, MODEL 8220, a class II device, cleared for Alaris Medical Systems, Inc. on under FDA product code DQA (Oximeter). FDA records list 26 510(k) clearances for CareFusion 303, INC, from to . As of , FDA records show 2 recalls naming K010966.

Clearance record

Decision date
Received
(67 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Alaris Medical Systems, Inc. 10221 Wateridge Cir., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code DQA

Trailing 12 months
12 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260