CHL · Class II · 21 CFR 862.1120

FDA Product Code CHL: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Leading manufacturers include Instrumentation Laboratory CO, Abbott Point of Care, Inc. and Nova Biomedical Corporation.

188
Total
188
Cleared
103d
Avg days
1976
Since
Declining activity - 3 submissions in the last 2 years vs 5 in the prior period
Review times increasing: avg 214d recently vs 101d historically

FDA 510(k) Cleared Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph Devices (Product Code CHL)

188 devices
1–24 of 188
Cleared Apr 10, 2026
ABL90 FLEX PLUS System, safeCLINITUBES
K252207
Radiometer Medicals Aps
Chemistry · 270d
Cleared May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014
Abbott Point of Care, Inc.
Chemistry · 127d
Cleared Dec 13, 2024
ABL90 FLEX PLUS System
K240998
Radiometer Medicals Aps
Chemistry · 246d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285
Abbott Point of Care, Inc.
Chemistry · 267d
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900
Nova Biomedical Corporation
Chemistry · 456d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Jan 27, 2023
EasyStat 300
K211559
Medica Corporation
Chemistry · 617d
Cleared Aug 20, 2021
GEM Premier 5000
K203790
Instrumentation Laboratory CO
Chemistry · 235d
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986
Opti Medical Systems, Inc.
Chemistry · 474d
Cleared Jun 05, 2020
epoc Blood Analysis System
K200107
Epocal, Inc.
Chemistry · 140d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492
Abbott Point of Care, Inc.
Chemistry · 41d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240
Siemens Healthcare Diagnostics, Inc.
Chemistry · 221d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jul 17, 2018
Stat Profile Prime Plus Analyzer System
K173797
Nova Biomedical Corporation
Chemistry · 215d
Cleared Dec 29, 2017
GEM Premier 5000
K173403
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Jan 13, 2014
GEM PREMIER 4000
K133407
Instrumentation Laboratory CO
Chemistry · 68d
Cleared Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974
Instrumentation Laboratory CO
Chemistry · 65d
Cleared Nov 24, 1999
GEM PREMIER 3000
K992834
Instrumentation Laboratory CO
Chemistry · 93d
Cleared Nov 13, 1996
IL SYNTHESIS
K963800
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Feb 14, 1996
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
K955793
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Mar 28, 1994
IL1430 BGELECTROLYTE ANALYZER
K935069
Instrumentation Laboratory CO
Chemistry · 154d
Cleared Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927
Instrumentation Laboratory CO
Chemistry · 38d

About Product Code CHL - Regulatory Context

510(k) Submission Activity

188 total 510(k) submissions under product code CHL since 1976, with 188 receiving FDA clearance (average review time: 103 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - CHL Product Code

Recent submissions under CHL have taken an average of 214 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.

CHL devices are reviewed by the Chemistry panel. Browse all Chemistry devices →