510(k) · Cleared
ClearedControl Plasma N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GIZ Plasma, Control, Normal
Cleared on May 24, 2000 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 24, 2000
- Review
- 35 days
- Class
- Class II
- Product code
- GIZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK001256 Control Plasma NDade Behring, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK023309 Control Plasma NDade Behring, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK013708 Reference Check, Catalog Number-RCN-10Precision Biologic · 2001
- Descendant · 2 generations on · 0 of its ownK091284 Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and…Affinity Biologicals, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK043451 Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed · 2005
- Descendant · 2 generations on · 0 of its ownK042333 Control Plasma N, Proc Control PlasmaDade Behring, Inc. · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K023309Control Plasma NDade Behring, Inc. · 2002 · cites it directly2descendants
- K013708Reference Check, Catalog Number-RCN-10Precision Biologic · 2001 · cites it directly1descendant
- K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaAffinity Biologicals, Inc. · 2009 · 2 generations on0descendants
- K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed · 2005 · cites it directly0descendants
- K042333Control Plasma N, Proc Control PlasmaDade Behring, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001256 | Control Plasma N | Dade Behring, Inc. | 2000 | — |
| +1 | K023309 | Control Plasma N | Dade Behring, Inc. | 2002 | — |
| +1 | K013708 | Reference Check, Catalog Number-RCN-10 | Precision Biologic | 2001 | — |
| +2 | K091284 | Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal… | Affinity Biologicals, Inc. | 2009 | — |
| +1 | K043451 | Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator | Hyphen Biomed | 2005 | — |
| +2 | K042333 | Control Plasma N, Proc Control Plasma | Dade Behring, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 GIZ? 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? (6)
3 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, K023309 (Dade Behring, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GIZ devicesGIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIZ
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GIZ
Too few GIZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GIZ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIZ
No MAUDE report names GIZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 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 | — | 1 | 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/K001256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001256: Control Plasma N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001256
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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