510(k) Report

510(k) · Cleared

Cleared

Omni Modular, Omni C and Omni S Analyzer (PH Electrode)

K050423510(k) TraditionalCleared Apr 22, 200563-day reviewClass II21 CFR 862.1120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Cleared on Apr 22, 2005 as substantially equivalent to K895317 (Avl Scientific Corp., 1990) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it.

Decided
Apr 22, 2005
Review
63 days
Class
Class II
Product code
CHL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K872888 (1987). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor2011: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant clearedK872888 · Ciba Corning 288 PH/Blood Gas System · Ciba Corning Diagnostics Corp. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant K872888 · Ciba Corning 288 PH/Blood Gas System · Ciba Corning Diagnostics Corp. · 19870+5
  1. Root · 1 generation backK872888 Ciba Corning 288 PH/Blood Gas SystemCiba Corning Diagnostics Corp. · 1987
  2. This deviceK050423 Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005
  3. Descendant · cites it directly · 5 of its ownK110416 ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK122539 Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013
  5. Descendant · 3 generations on · 3 of its ownK192240 RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · Recalled
  6. Descendant · 4 generations on · 1 of its ownK223857 i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · Recalled
  7. Descendant · 5 generations on · 0 of its ownK244014 i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12013: 12020: 12023: 22025: 1
2010high 2 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · cites it directly5descendants
  • K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013 · 2 generations on4descendants
  • K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · 3 generations on3descendants
  • K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 4 generations on1descendant
  • K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872888Ciba Corning 288 PH/Blood Gas SystemCiba Corning Diagnostics Corp.1987—
0 (this device)K050423Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics2005—
+1K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps20112
+2K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics2013—
+3K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.20204
+4K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20231
+5K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20251

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201310
202010
202320
202510
FIG. 1 — Lineage of K050423, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CHL device

  1. #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K895317Avl Model 995HB PH/Blood Gas Analyzer
Summary page 1
…te The OMNI Analyzers (OMNI Modular, OMNI C and OMNI S) are device substantially equivalent to the AVL model 995-Hb pH/blood gas analyzer (K895317) and the CIBA-Corning Model 288 blood gas system (K872888). The AVL 995-Hb and CIBA-Coming 288 were the analyzer…
Avl Scientific Corp.1990—
*K872888Ciba Corning 288 PH/Blood Gas System
Summary page 1
…) are device substantially equivalent to the AVL model 995-Hb pH/blood gas analyzer (K895317) and the CIBA-Corning Model 288 blood gas system (K872888). The AVL 995-Hb and CIBA-Coming 288 were the analyzers used in the studies described in the pe…
Ciba Corning Diagnostics Corp.1987—

Also cleared against K895317: 5 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps20115
K100777ABL837 Flex AnalyzerRadiometer Medical Aps20100

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K110416 (Radiometer Medical Aps, 2011) has gone furthest, with 5 descendants of its own.
  • 5 other devices also cite its predicate K895317.

How does its category compare?

All CHL devices

CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHL

1in 2025

2007: 12008: 12010: 12011: 42012: 42013: 52014: 32015: 42016: 32017: 12018: 12020: 42021: 22023: 52024: 12025: 12026 (partial year): 1
2007high 5 (2013) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CHL

267in 2023

2011: 108 days median2012: 65 days median2013: 152 days median2014: 68 days median2015: 155 days median2016: 306 days median2020: 100 days median2023: 267 days median
2007high 306 (2016) · low 65 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CHL

13so far in 2026, the most since 2007

2007: 62008: 52009: 62010: 72011: 12012: 92013: 12014: 12015: 32016: 12017: 12018: 32020: 22023: 42024: 92026 (partial year): 13
2007high 13 (2026) · low 0 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CHL

210in 2025

2007: 162008: 402009: 742010: 202011: 502012: 642013: 622014: 932015: 552016: 1182017: 2062018: 1742019: 1412020: 1172021: 1472022: 1382023: 1772024: 1962025: 210
2007high 210 (2025) · low 16 (2007)2025

MAUDE reports naming product code CHL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—616
20081—540
20090—674
20101—720
20114108150
2012465964
20135152162
2014368193
20154155355
201633061118
20171—1206
20181—3174
20190—0141
202041002117
20212—0147
20220—0138
202352674177
20241—9196
20251—0210
20261—13—

What is it indicated for?

The Omni (Modular, C and S) can be used for the measurement of ph in pleural fluid, as long as care is taken to ensure that the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport system.

The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.

Indications for use as stated in the FDA summary.

Also cleared against K895317

5 other devices cite the same predicate.

  • K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 20054 recalls
  • K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  • K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  • K963964Avl Compact 3 PH/Blood Gas AnalyzerAvl Scientific Corp. · 1996
  • K961161Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp. · 1996

More from Roche Diagnostics

207 FDA decisions under this applicant name. See the company

  • DEN260027Elecsys HBsAg II quant II RxDxRoche Diagnostics · 2026
  • K260232Elecsys EBV VCA IgGRoche Diagnostics · 2026
  • K260233Elecsys EBV IgMRoche Diagnostics · 2026
  • K260221Elecsys EBV EBNA IgGRoche Diagnostics · 2026
  • K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics · 2026

Recent decisions in CHL

The CHL category page

  • K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps · 2026
  • K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 20251 recall
  • K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024
  • K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
  • K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2023

https://510kreport.com/device/K050423 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050423: Omni Modular, Omni C and Omni S Analyzer (PH Electrode).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050423

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026