510(k) · Cleared
ClearedLiasys 450
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 8, 2012 after a 136-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 8, 2012
- Review
- 136 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The "LIASYS 450 SAT 450' is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. Qther various chemistry assays are adaptable to this instrument. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia and…
Read the full statement (134 words)
The "LIASYS 450 SAT 450' is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. Qther various chemistry assays are adaptable to this instrument.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia and idiopathic hypoglytemnia and of pancreatic islet cell carcinoma. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of' electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113131: Liasys 450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113131
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026