510(k) · Cleared
ClearedIcs Pab Prealbumin Reagent Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DDS Prealbumin, Fitc, Antigen, Antiserum, Control
Cleared on Jan 24, 1986 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jan 24, 1986
- Review
- 52 days
- Class
- Class I
- Product code
- DDS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK854811 Ics Pab Prealbumin Reagent Test KitBeckman Instruments, Inc. · 1986
- Descendant · cites it directly · 1 of its ownK994168 Synchron LX Systems Prealbumin CalibratorBeckman Coulter, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK994169 Synchron CX Systems Prealbumin CalibratorBeckman Coulter, Inc. · 2000
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854811 | Ics Pab Prealbumin Reagent Test Kit | Beckman Instruments, Inc. | 1986 | — |
| +1 | K994168 | Synchron LX Systems Prealbumin Calibrator | Beckman Coulter, Inc. | 2000 | — |
| +1 | K994169 | Synchron CX Systems Prealbumin Calibrator | Beckman Coulter, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DDS? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K994168 (Beckman Coulter, Inc., 2000) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DDS devicesDDS Prealbumin, Fitc, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDS
FDA has decided no DDS device since 2007.
Median 510(k) review, days · DDS
Too few DDS 510(k)s in any year since 2007 to give a median.
Recalls per year · DDS
No recall names DDS since 2007.
Adverse event reports per year · DDS
No MAUDE report names DDS since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K854811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854811: Ics Pab Prealbumin Reagent Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854811
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026