510(k) · Cleared
ClearedSentinel Cholinesterase Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Ch. Srl · DIH Colorimetry, Cholinesterase
Cleared on Jun 20, 2005 as substantially equivalent to K981800 (Equal Diagnostics, Inc., 1998) after an 18-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 20, 2005
- Review
- 18 days
- Class
- Class I
- Product code
- DIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981800 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981800 Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606Equal Diagnostics, Inc. · 1998
- This deviceK051444 Sentinel Cholinesterase LiquidSentinel Ch. Srl · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981800 | Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606 | Equal Diagnostics, Inc. | 1998 | — |
| 0 (this device) | K051444 | Sentinel Cholinesterase Liquid | Sentinel Ch. Srl | 2005 | — |
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 DIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K981800 | Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606Summary page 1…Sentinel Cholinesterase Liquid assay is substantially equivalent to the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717 (K981800). The modifications consisted of the adaptation of the general purpose Sentinel Cholinesterase Liquid Model Number 17.019A and… | 1998 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DIH devicesDIH Colorimetry, Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIH
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · DIH
Too few DIH 510(k)s in any year since 2007 to give a median.
Recalls per year · DIH
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIH
1in 2024
MAUDE reports naming product code DIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inlhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051444: Sentinel Cholinesterase Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051444
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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