510(k) · Cleared
ClearedSdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemodiagnostica, LLC · CFR Hexokinase, Glucose
Cleared on Dec 15, 2006 as substantially equivalent to K872302 (Ciba Corning Diagnostics Corp., 1987) and 3 other predicates after a 165-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Dec 15, 2006
- Review
- 165 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K871028 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK871028 Ciba Corning Model 664/Fast 4 SystemCiba Corning Diagnostics Corp. · 1987
- This deviceK061879 Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry…Hemodiagnostica, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871028 | Ciba Corning Model 664/Fast 4 System | Ciba Corning Diagnostics Corp. | 1987 | — |
| 0 (this device) | K061879 | Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System | Hemodiagnostica, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K872302 | Model 550 Express Clinical Chemistry AnalyzerSummary page 2…e diagnosis and treatment of electrolyte and metabolic disorders. Predicate Device: Ciba Corning Model 550 Express Clinical Chemistry Analyzer 510(k): K872302 Ciba Corning Model 664/Fast 4 System 510(k): K871028 The following table describes the predicate devices, classi… | 1987 |
| * | K871028 | Ciba Corning Model 664/Fast 4 SystemSummary page 2…rders. Predicate Device: Ciba Corning Model 550 Express Clinical Chemistry Analyzer 510(k): K872302 Ciba Corning Model 664/Fast 4 System 510(k): K871028 The following table describes the predicate devices, classifications, corresponding regulations, and product codes ass… | 1987 |
| * | K880078 | Urea Nitrogen (Bun)Summary page 2…S ystem Corning I 862.1665 UREA NITROGEN K880078 I CDQ 862.1770 (BUN) GLUCOSE… | 1988 |
| * | K880236 | Glucose HexokinaseSummary page 2…CDQ 862.1770 (BUN) GLUCOSE HEXOKINASE K880236 II CFR 862.1345 Confidential… | 1988 |
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.
What does this lineage say?
- None of the 4 ancestors has a recall.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders…
Read the full statement (141 words)
The SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. BUN measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and are used 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061879: Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061879
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026