510(k) · Cleared
ClearedIrma Blood Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diametrics Medical, Inc. · CGZ Electrode, Ion-Specific, Chloride
Cleared on May 1, 1998 after a 24-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- May 1, 1998
- Review
- 24 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK981270 Irma Blood Analysis SystemDiametrics Medical, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK013624 Modification to Agilent Component Monitoring System (CMS), V24/V26…Philips Medizin Systeme Boblingen GmbH · 2001
Most influential descendants
Showing 4 of 4 · See all- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
- K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 2 generations on1descendant
- K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 3 generations on0descendants
- K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981270 | Irma Blood Analysis System | Diametrics Medical, Inc. | 1998 | — |
| +1 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| +2 | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +3 | K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021 | — |
| +1 | K013624 | Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient… | Philips Medizin Systeme Boblingen GmbH | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
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 CGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Johnson and Johnson Vitros Chemistry System DT60II Named without a submission number | |
| * | — | Buchler Digital Chloridometer Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K993837 (Avl Scientific Corp., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na, K, iCa , BUN, CI', and Hct, in whole blood are performed such as the clinical laboratory or the patient bedside. The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include…
Read the full statement (235 words)
The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na, K, iCa , BUN, CI', and Hct, in whole blood are performed such as the clinical laboratory or the patient bedside.
The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include: cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance.
The electrolyte measurements (Na , K, ClI') are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states which utilize these measurements for diagnosis are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.
The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients.
The measurement of blood urea nitrogen is used to monitor renal disease, dialysis patients, and hyperalimentation.
The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia.
With the addition of BUN and CI', the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arrays of the cartridge will also be packaged in various combinations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981270: Irma Blood Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981270
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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