MUD · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-08-29 → 2026-05-22

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Edwards Lifesciences, LLC	4	0	2024-10-16
Vioptix, Inc.	3	0	2025-06-26
Masimo Corporation	3	0	2025-07-17
Kent Imaging, Inc.	2	0	2024-04-02
Odi Medical AS	1	0	2024-08-30
Covidien, LLC	1	0	2021-12-05
Neko Health AB	1	1	2026-05-22
Iss Medical, Inc.	1	0	2024-03-01

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
94060	CPT	—	High	CPT for non-invasive oximetry measurement
94062	CPT	—	Medium	CPT for oximetry during exercise or stress testing

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-22	K254129	Neko Health AB	Spectrum-2
2025-07-17	K243324	Masimo Corporation	Masimo O3 Regional Oximeter
2025-06-26	K250519	ViOptix, Inc.	Lap.Ox Laparoscopic Tissue Oximeter
2024-10-16	K240596	Edwards Lifesciences	Cerebral Autoregulation Index (CAI) Algorithm
2024-08-30	K241393	Odi Medical AS	ODI-Tech
2024-04-02	K240601	Kent Imaging, Inc.	SnapshotNIR model KD205
2024-03-01	K232385	Iss Medical, Inc.	OxiplexTS200
2024-02-28	K233488	Vioptix, Inc.	Intra.Ox 2.0 Handheld Tissue Oximeter
2023-11-17	K230612	Edwards Lifesciences, LLC	Edwards Algorithm for Measurement of Blood Hemoglobin
2023-05-26	K223651	Edwards Lifesciences, LLC	Cerebral Adaptive Index (CAI) Algorithm
2022-05-06	K214072	Masimo Corporation	Masimo O3 Regional Oximeter System
2022-05-03	K221010	Vioptix, Inc.	Intra.Ox 2.0 Handheld Tissue Oximeter
2021-12-05	K211561	Covidien, LLC	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
2021-02-10	K203490	Edwards Lifesciences, LLC	FORE-SIGHT ELITE Absolute Tissue Oximeter
2020-11-10	K201976	Kent Imaging	SnapshotNIR
2020-08-29	K201432	Masimo Corporation	Masimo O3 Regional Oximeter System

MUD · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances