510(k) · Cleared
ClearedBeckman Transferrin Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Oct 7, 1993 after a 293-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 7, 1993
- Review
- 293 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK926272 Beckman Transferrin KitBeckman Instruments, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK972840 N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK053075 N Antisera to Human TransferrinDade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK973928 Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997
- Descendant · 3 generations on · 0 of its ownK182095 Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) · 2018
- Descendant · 3 generations on · 0 of its ownK081299 Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997 · cites it directly4descendants
- K053075N Antisera to Human TransferrinDade Behring, Inc. · 2006 · 2 generations on3descendants
- K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997 · cites it directly1descendant
- K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) · 2018 · 3 generations on0descendants
- K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926272 | Beckman Transferrin Kit | Beckman Instruments, Inc. | 1993 | — |
| +1 | K972840 | N Antiserum to Human Transferrin | Behring Diagnostics, Inc. | 1997 | — |
| +2 | K053075 | N Antisera to Human Transferrin | Dade Behring, Inc. | 2006 | — |
| +1 | K973928 | Beckman Urine Protein Calibrator (Ucal) | Beckman Instruments, Inc. | 1997 | — |
| +3 | K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018 | — |
| +3 | K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 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 DDG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DDG device
- #1 K240987 Access sTfRscore 8.2 · 3 generations · no Class I recall
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? (9)
4 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, K972840 (Behring Diagnostics, Inc., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DDG
114in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DDG
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDG
1in 2015
MAUDE reports naming product code DDG, 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 | 4 | 114 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K926272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926272: Beckman Transferrin Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926272
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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