CHL · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-01-24 → 2026-04-10

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
Abbott Point of Care, Inc.	4	0	2025-05-02
Radiometer Medicals Aps	2	1	2026-04-10
Instrumentation Laboratory CO	2	0	2023-08-10
Nova Biomedical Corporation	2	0	2023-09-29
Opti Medical Systems, Inc.	1	0	2021-08-02
Medica Corporation	1	0	2023-01-27
Epocal, Inc.	1	0	2020-06-05
Siemens Healthcare Diagnostics, Inc.	1	0	2020-03-27

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
82803	CPT	—	High	Standard CPT for blood gases (pH, pCO2, pO2) electrode measurement

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-10	K252207	Radiometer Medicals Aps	ABL90 FLEX PLUS System, safeCLINITUBES
2025-05-02	K244014	Abbott Point of Care, Inc.	i-STAT CG4+ cartridge with the i-STAT 1 System
2024-12-13	K240998	Radiometer Medicals Aps	ABL90 FLEX PLUS System
2023-10-27	K230285	Abbott Point of Care, Inc.	i-STAT CG8+ cartridge with the i-STAT 1 System
2023-09-29	K221900	Nova Biomedical Corporation	Stat Profile Prime Plus Analyzer System
2023-09-15	K223857	Abbott Point of Care, Inc.	i-STAT G3+ cartridge with the i-STAT 1 System
2023-08-10	K223608	Instrumentation Laboratory Company	GEM Premier 7000 with IQM3
2023-01-27	K211559	Medica Corporation	EasyStat 300
2021-08-20	K203790	Instrumentation Laboratory CO	GEM Premier 5000
2021-08-02	K200986	Opti Medical Systems, Inc.	OPTI® B-Lac Cassette
2020-06-05	K200107	Epocal, Inc.	epoc Blood Analysis System
2020-04-09	K200492	Abbott Point of Care, Inc.	i-STAT CG4+ Cartridge with the i-STAT 1 System
2020-03-27	K192240	Siemens Healthcare Diagnostics, Inc.	RAPIDPoint 500e Blood Gas System
2020-01-24	K193246	Nova Biomedical Corporation	Stat Profile Prime Plus Analyzer System

CHL · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances