# K974818: ABL555 Blood Gas, Electrolyte & Metabolite System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Jan 16, 1998 after 24 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914166 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973367: ABL555 Blood Gas, Electrolyte & Metabolite System, Radiometer America, Inc. (1997) Summary page 1.
- (no number) EML10S: named in the summary without a submission number
- (no number) i-STAT Model 100: named in the summary without a submission number
- (no number) Corning 348: named in the summary without a submission number

## Recalls of this device
- Apr 7, 2011 · Not classified · Z-2571-2011: Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of 

## Indications for use
ABLSSS is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO; pO;Na“, K*, Hct, and the option of one of the following parameters: CL= or Ca® gor Glucose or Lactate.

Source page: https://510kreport.com/device/K974818
Methodology: https://510kreport.com/methodology