# K991417: Abl 735 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Nov 24, 1999 after 215 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952621 (1995). 8 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System, Radiometer America, Inc. (1998) Summary page 1.
- K922770: Unistat Bilirubinometer Models 10310 and 10311, Leica, Inc. (1992) Summary page 1.
- K790608: BL Bilirubinometer, Advanced Instruments, Inc. (1979) Summary page 1.
- K840880: Ektachem Clinical Chem. Slides, Eastman Kodak Company (1984) Summary page 1.

## Cited in the summary but kept off the family tree
- K340606: Vitros. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to (2010), 12 descendants of its own
- K112995: Gem Premier 4000 (2012), 11 descendants of its own
- K133407: Gem Premier 4000 (2014), 10 descendants of its own
- K173403: GEM Premier 5000 (2017), 2 descendants of its own
- K160225: GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator (2016), 2 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH,p02,.pCO02, potassium, sodium, calcium, chloride, glucose, 1actate, total bilirubin, and coOoximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions f02Hb, fCOHb fMetHb fHHD, and fHbLF)

Source page: https://510kreport.com/device/K991417
Methodology: https://510kreport.com/methodology