# K945240: Irma Blood Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: Jan 5, 1995 after 70 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974784: Avl Opti Critical Care Analyzer (1998), 5 descendants of its own
- K984299: Avl Opti Critical Care Analyzer (1998), 4 descendants of its own
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own
- K131126: Opti Cca-TS2 (2013), 1 descendant of its own
- K200986: OPTI® B-Lac Cassette (2021), 0 descendants of its own

## Recalls of this device
- Sep 16, 2015 · Class II · Z-0160-2016: 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 
- Sep 16, 2015 · Class II · Z-0159-2016: 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 
- Apr 29, 2015 · Class II · Z-1919-2015: 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: An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

Source page: https://510kreport.com/device/K945240
Methodology: https://510kreport.com/methodology