SnapshotNIR model KD205

FDA 510(k) K240601 · Kent Imaging, Inc.

Substantially Equivalent

510(k) numberK240601

Submission

Device name
SnapshotNIR model KD205
Applicant
Kent Imaging, Inc.
Calgary, CA
Received
March 4, 2024
Decision date
April 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
MUD – Oximeter, Tissue Saturation
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

Other 510(k)s with product code MUD

510(k)DeviceApplicantDecision
K254129Spectrum-2MUD · Traditional Neko Health AB05/22/2026SE
K243324Masimo O3 Regional OximeterMUD · Traditional Masimo Corporation07/17/2025SE
K250519Lap.Ox™ Laparoscopic Tissue OximeterMUD · Traditional ViOptix, Inc.06/26/2025SE
K240596Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional Edwards Lifesciences10/16/2024SE
K241393ODI-TechMUD · Traditional Odi Medical AS08/30/2024SE
K232385OxiplexTS200MUD · Traditional Iss Medical, Inc.03/01/2024SE
K233488Intra.Ox™ 2.0 Handheld Tissue OximeterMUD · Traditional Vioptix, Inc.02/28/2024SE
K230612Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional Edwards Lifesciences, LLC11/17/2023SE
K223651Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional Edwards Lifesciences, LLC05/26/2023SE
K214072Masimo O3 Regional Oximeter SystemMUD · Traditional Masimo Corporation05/06/2022SE

More from Masimo Corporation

510(k)DeviceDecision
K242669SnapshotGLO (KB100)QJF · Traditional 03/26/2025SE
K201976SnapshotNIRMUD · Traditional 11/10/2020SE
K163070Kent CameraMUD · Traditional 05/05/2017SE
K113507Kent CameraMUD · Traditional 08/08/2012SE

Questions and answers

When was SnapshotNIR model KD205 cleared by the FDA?

SnapshotNIR model KD205 (K240601) received a 510(k) decision of Substantially Equivalent on April 2, 2024, 29 days after the submission was received.

What is the product code of K240601?

The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.