510(k) · Cleared
ClearedControl Plasma P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GGC Control, Plasma, Abnormal
Cleared on Nov 1, 2002 as substantially equivalent to K924405 (Behring Diagnostics, Inc., 1992) after a 29-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Nov 1, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- GGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924405 (1992). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K042209Control Plasma N and Control Plasma PDade Behring, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924405 | Control Plasma P | Behring Diagnostics, Inc. | 1992 | — |
| 0 (this device) | K023312 | Control Plasma P | Dade Behring, Inc. | 2002 | — |
| +1 | K042209 | Control Plasma N and Control Plasma P | Dade Behring, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 GGC? 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 |
|---|---|---|---|
| * | K924405 | Control Plasma PSummary page 2…Multipurpose system for in vitro coagulation studies, Class II (864.5425) 3. Identification of the Legally Marketed Device: Control Plasma P (K924405) 4. Device Description: Control Plasma P is a lyophilized control prepared from pooled human plasma, a… | 1992 |
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 |
|---|---|---|---|
| K042209 | Control Plasma N and Control Plasma P | 2004 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K042209 (Dade Behring, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGC devicesGGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGC
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · GGC
Too few GGC 510(k)s in any year since 2007 to give a median.
Recalls per year · GGC
No recall names GGC since 2007.
Adverse event reports per year · GGC
1in 2021
MAUDE reports naming product code GGC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 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 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range:
7. Prothrombin time (PT)
2. Activated partial thromboplastin time (aPTT)
3, Fibrinogen (Clauss method)
4. Ccmgukdionicrt-iars i i , V, iiii, Viii, vkVF, iii, XI Xi, ana X I I
5. Inhibitors: Antithrombin Ill, protein C, protein S, a:-antiplasrnin
6. Plasminogen
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023312: Control Plasma P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023312
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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