Cleared Traditional

ANNE Limb

K240305 · Sibel Health, Inc. · Cardiovascular
May 2024
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K240305 is an FDA 510(k) clearance for the ANNE Limb, a Oximeter (Class II — Special Controls, product code DQA), submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on May 28, 2024, 116 days after receiving the submission on February 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K240305 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2024
Decision Date May 28, 2024
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

Similar Devices — DQA Oximeter

All 721
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL? Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
K251691 · Unimed Medical Supplies, Inc. · Dec 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
K251696 · Unimed Medical Supplies, Inc. · Dec 2025