510(k) · Cleared
Recalled · Class II · 2015Irma Blood Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diametrics Medical, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jan 5, 1995 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 5, 1995
- Review
- 70 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK945240 Irma Blood Analysis SystemDiametrics Medical, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- Descendant · cites it directly · 4 of its ownK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- Descendant · 2 generations on · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
- Descendant · 3 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly5descendants
- K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly4descendants
- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · 2 generations on2descendants
- K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 3 generations on1descendant
- K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945240 | Irma Blood Analysis System | Diametrics Medical, Inc. | 1995 | — |
| +1 | K974784 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +1 | K984299 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +2 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| +3 | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +4 | K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2015 | Class II | Z-0160-2016 | Nonconforming Material/Component | May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen… |
| Sep 16, 2015 | Class II | Z-0159-2016 | Nonconforming Material/Component | May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen… |
| Apr 29, 2015 | Class II | Z-1919-2015 | Nonconforming Material/Component | The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time. |
| Jul 14, 2003 | Not classified | Z-1072-03 | Other | An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K974784 (Avl Scientific Corp., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All CHL devicesCHL 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
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
https://510kreport.com/device/K945240 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945240: 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/K945240
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026