CCK · Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device class

Class II

Regulation 868.1400

Total clearances

2020-01-17 → 2026-08-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.1400

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Covidien, LLC	4	1	2026-05-01
Beijing Kingst Commercial & Trade Co., Ltd.	2	0	2020-05-22
Nihon Kohden Corporation	2	1	2026-08-12
Endure Industries, Inc.	1	0	2023-09-12
Affirm Medical Technologies II, LLC	1	1	2026-07-14
Meditera Tibbi Malzeme San VE Tic AS	1	0	2020-01-17
Vyaire Medical, Inc.	1	0	2024-11-12
Unimed Medical Supplies, Inc.	1	0	2021-03-04
Prior Care Science Technology, Ltd.	1	1	2025-08-28
Barbaras Development, Inc.	1	0	2025-06-04
Inventeur, LLC	1	0	2024-12-16
Southmedic, Inc.	1	0	2023-11-21
Pneuma Therapeutics, Inc.	1	0	2023-01-30
Engineered Medical Systems, Inc.	1	0	2022-11-16
Exostat Medical, Inc.	1	0	2024-11-07
Masimo Corporation	1	0	2021-03-29
Draegerwerk AG & CO Kgaa	1	0	2023-04-05
GE Healthcare Finland Oy	1	0	2021-10-21
Oridion Medical 1987 , Ltd.	1	0	2020-04-27

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
82374	CPT	—	Medium	CO2 blood gas measurement; device is analyzer but billing typically bundles into ABG panel codes
0510T	CPT	—	Low	Expired/obscure anesthesia monitoring code; may not apply to standalone analyzer

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-12	K251641	Nihon Kohden Corporation	GF-310R Multigas Unit (GF-310R)
2026-07-14	K261633	Affirm Medical Technologies II, LLC	VisuBreath
2026-05-01	K253030	Covidien, LLC	Capnostream35 Portable Respiratory Monitor (PM35MN)
2025-08-28	K250148	Prior Care Science Technology, Ltd.	Medical Gas Analyzer (AG200)
2025-06-10	K243956	Nihon Kohden Corporation	TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
2025-06-04	K251216	Barbaras Development, Inc.	0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
2024-12-16	K240937	Inventeur, LLC	AIM (N/A)
2024-11-12	K230915	Vyaire Medical, Inc.	AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
2024-11-07	K212425	Exostat Medical, Inc.	MicroTrend System
2023-11-21	K222511	Southmedic, Inc.	Oxy2Pro
2023-09-12	K213767	Endure Industries, Inc.	Endure ETCO2/02 Nasal Cannula
2023-04-05	K221118	Draegerwerk AG & CO Kgaa	CO2 Mainstream Sensor
2023-01-30	K210112	Pneuma Therapeutics, Inc.	XChange Device, XChange System
2022-11-16	K220533	Engineered Medical Systems, Inc.	Endoscopy Oxygen Mask
2022-07-29	K213911	Covidien, LLC	Microstream CO2 NanoPod
2022-04-12	K213518	Covidien, LLC	CARESCAPE CO2 Microstream parameter
2021-10-21	K211171	GE Healthcare Finland Oy	CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
2021-09-17	K203762	Covidien	Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
2021-03-29	K201590	Masimo Corporation	EMMA Capnograph
2021-03-04	K210019	Unimed Medical Supplies, Inc.	Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
2020-05-22	K192488	Beijing Kingst Commercial & Trade Co., Ltd.	CO2 Sidestream Module
2020-05-21	K192446	Beijing Kingst Commercial & Trade Co., Ltd.	CO2 Mainstream Module
2020-04-27	K200594	Oridion Medical 1987 , Ltd.	Capnostream 35 Portable Respiratory Monitor
2020-01-17	K192563	Meditera Tibbi Malzeme San VE Tic AS	Altera gas Sampling Lines