510(k) · Cleared
Recalled · Class I · 2021Leadcare (R) Ultra (TM) Blood Lead Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magellan Diagnostics · DOF Lead, Atomic Absorption
Cleared on Aug 20, 2013 as substantially equivalent to K052549 (Esa Biosciences, Inc., 2005) after a 274-day review. Its family tree reaches back 2 generations to 1997. 4 of the 4 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Aug 20, 2013
- Review
- 274 days
- Class
- Class II
- Product code
- DOF
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971640 (1997). 1 later device descends from it, 1 citing it directly. 4 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK971640 Leadcare Blood Lead Testing SystemEsa, Inc. · 1997 · Recalled (Class I)
- 1 generation backK052549 Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 2005 · Recalled (Class I)
- This deviceK123563 Leadcare (R) Ultra (TM) Blood Lead Testing SystemMagellan Diagnostics · 2013
- Descendant · cites it directly · 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 1 of 1 · See all- K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971640 | Leadcare Blood Lead Testing System | Esa, Inc. | 1997 | Class I |
| −1 | K052549 | Leadcare II Blood Lead Testing System | Esa Biosciences, Inc. | 2005 | Class I |
| 0 (this device) | K123563 | Leadcare (R) Ultra (TM) Blood Lead Testing System | Magellan Diagnostics | 2013 | — |
| +1 | K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
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.
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? (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 |
|---|---|---|---|
| * | K052549 | Leadcare II Blood Lead Testing SystemSummary page 1…Class II Product Code: DOF 5 10(k) Number: k123563 3. PREDICATE DEVICE *LeadCare® 11 Blood Lead Testing System (k052549) 4. DEVICE DESCRIPTION The LeadCare Ultra System Blood Lead Testing System is an in vitro diagnostic device t… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142705 | LeadCare Plus Blood Lead Testing System Class I | 2015 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2021 | Class I | Z-1954-2021 | Nonconforming Material/Component | Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples. |
| Nov 29, 2014 | Class I | Z-1925-2017 | Device Design | LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the… |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K971640Leadcare Blood Lead Testing SystemEsa, Inc. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K142705LeadCare Plus Blood Lead Testing SystemMagellan Diagnostics · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K142705 (Magellan Diagnostics, 2015) has gone furthest, with 0 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. 2013, this device’s year, is highlighted.
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® UltraTM Blood Lead Testing System is designed to quantitatively measure the amount of lead in a whole blood sample. The LeadCare® UltraTM Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use only with the LeadCare® Ultrarm Blood Lead Testing System.
This test system is for prescription use only. This system is not intended for point of care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123563: Leadcare (R) Ultra (TM) Blood Lead Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123563
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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