510(k) · Cleared
Recalled · Class I · 2018Leadcare Blood Lead Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esa, Inc. · DOF Lead, Atomic Absorption
Cleared on Sep 9, 1997 after a 130-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Sep 9, 1997
- Review
- 130 days
- Class
- Class II
- Product code
- DOF
- Recalls
- 3 (1 Class I)
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 4 of the 4 devices in this family, counting this one, have a Class I recall.
- This deviceK971640 Leadcare Blood Lead Testing SystemEsa, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK052549 Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK123563 Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK142705 LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K052549Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 2005 · cites it directly2descendants
- K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 2013 · 2 generations on1descendant
- K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971640 | Leadcare Blood Lead Testing System | Esa, Inc. | 1997 | — |
| +1 | K052549 | Leadcare II Blood Lead Testing System | Esa Biosciences, Inc. | 2005 | Class I |
| +2 | K123563 | Leadcare (R) Ultra (TM) Blood Lead Testing System | Magellan Diagnostics | 2013 | Class I |
| +3 | K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 1 |
| 2013 | 1 | 1 |
| 2015 | 1 | 1 |
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.
4 devices in this family have a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052549 | Leadcare II Blood Lead Testing System Class I | 2005 | 2 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2018 | Class II | Z-0285-2019 | Process control | Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed as HIGH. |
| May 23, 2017 | Class I | Z-2225-2017 | Device Design | Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems |
| May 19, 2005 | Not classified | Z-0914-05 | Other | Lead test results may be reported lower than the actual value |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052549Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
- K123563Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K052549 (Esa Biosciences, Inc., 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DOF devicesDOF Lead, Atomic Absorption: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DOF
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DOF
Too few DOF 510(k)s in any year since 2007 to give a median.
Recalls per year · DOF
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DOF
55in 2025
MAUDE reports naming product code DOF, 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 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 39 |
| 2018 | 0 | — | 1 | 40 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 98 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The LEADCARE System is suitable for use in a physcian’s office laboratory environment (POL).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971640: Leadcare Blood Lead Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971640
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026