510(k) · Cleared
Recalled · Class II · 2012Access Folate Calibrators on the Access Immunoassay Systems Model A98033
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIT Calibrator, Secondary
Cleared on Aug 19, 2011 as substantially equivalent to K060774 (Beckman Coulter, Inc., 2006) after a 39-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 19, 2011
- Review
- 39 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932887 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932887 Access Folate AssayBeckman Coulter, Inc. · 1993
- 1 generation backK060774 Folate on the Access Immunoassay Systems, Model A14208Beckman Coulter, Inc. · 2006 · Recalled
- This deviceK111952 Access Folate Calibrators on the Access Immunoassay Systems Model…Beckman Coulter, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK223590 Access Folate AssayBeckman Coulter, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223590Access Folate AssayBeckman Coulter, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932887 | Access Folate Assay | Beckman Coulter, Inc. | 1993 | — |
| −1 | K060774 | Folate on the Access Immunoassay Systems, Model A14208 | Beckman Coulter, Inc. | 2006 | 1 |
| 0 (this device) | K111952 | Access Folate Calibrators on the Access Immunoassay Systems Model A98033 | Beckman Coulter, Inc. | 2011 | — |
| +1 | K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 JIT? 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 |
|---|---|---|---|
| * | K060774 | Folate on the Access Immunoassay Systems, Model A14208Summary page 1…Calibrator Classification Name: Calibrator Predicate Device Access Folate Calibrator Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MVN 55315 510(k) Number: k060774 Device Description The Access Folate Calibrators are a six level calibrator set intended to calibrate the Access Folate assay fo… | 2006 |
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 |
|---|---|---|---|
| K223590 | Access Folate Assay | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2012 | Class II | Z-0047-2013 | Nonconforming Material/Component | Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 12.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K223590 (Beckman Coulter, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K060774.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Access Folate Calibrators are intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111952: Access Folate Calibrators on the Access Immunoassay Systems Model A98033.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111952
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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