# K002290: Abl-700 Series, Model Abl 7XX (Various Models)

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical A/S
- Decided: Sep 13, 2000 after 48 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: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K041874: ABL800 Flex (2004), 29 descendants of its own
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own
- K092686: ABL90 Flex Series (2010), 12 descendants of its own
- K120197: ABL90 Flex (2012), 6 descendants of its own
- K122729: ABL90 Flex (2012), 5 descendants of its own

## Recalls of this device
- Oct 8, 2012 · Class II · Z-2303-2013: RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the 
- Jul 5, 2012 · Class II · Z-2163-2012: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the 
- Jul 5, 2012 · Class II · Z-2162-2012: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the 
- Apr 16, 2009 · Not classified · Z-1554-2009: When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
- Sep 5, 2008 · Not classified · Z-0457-2009: The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequ
- Jan 18, 2008 · Not classified · Z-1653-2008: Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause th
- Nov 13, 2006 · Not classified · Z-1094-2007: Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the el
- Sep 29, 2005 · Not classified · Z-1386-06: Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too lo
- Jun 17, 2005 · Not classified · Z-1317-06: Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

Source page: https://510kreport.com/device/K002290
Methodology: https://510kreport.com/methodology