510(k) · Cleared

Cleared

Control Plasma N

K023309510(k) TraditionalCleared Nov 1, 200229-day reviewClass II21 CFR 864.5425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · GIZ Plasma, Control, Normal

Cleared on Nov 1, 2002 as substantially equivalent to K001256 (Dade Behring, Inc., 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided: Nov 1, 2002
Review: 29 days
Class: Class II
Product code: GIZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001256 (2000). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK001256 Control Plasma NDade Behring, Inc. · 2000
This deviceK023309 Control Plasma NDade Behring, Inc. · 2002
Descendant · cites it directly · 0 of its ownK042333 Control Plasma N, Proc Control PlasmaDade Behring, Inc. · 2004
Descendant · cites it directly · 0 of its ownK042209 Control Plasma N and Control Plasma PDade Behring, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all

K042333Control Plasma N, Proc Control PlasmaDade Behring, Inc. · 2004 · cites it directly0descendants
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	K001256	Control Plasma N	Dade Behring, Inc.	2000	—
0 (this device)	K023309	Control Plasma N	Dade Behring, Inc.	2002	—
+1	K042333	Control Plasma N, Proc Control Plasma	Dade Behring, Inc.	2004	—
+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	2	0

FIG. 1 — Lineage of K023309, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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	Applicant	Decided	Recalls
*	K001256	Control Plasma N	Dade Behring, Inc.	2000	—

Also cleared against K001256: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042333	Control Plasma N, Proc Control Plasma	Dade Behring, Inc.	2004	0
K042209	Control Plasma N and Control Plasma P	Dade Behring, Inc.	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, K042333 (Dade Behring, Inc., 2004) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K001256.

How does its category compare?

All GIZ devices

GIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GIZ

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

2007high 1 (2019) · low 0 (2007)2026

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	—

What is it indicated for?

Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range:

1. Prothrombin time (PT)

2. Activated partial thromboplastin time (aPTT)

3. Thrombin time (TT)'

4. Batroxobin time*

5. Fibrinogen

6. Coagulation factors I I , V, VII, VIII, vWF, IX, X , XI, and XI1

7. Inhibitors: Antithrombin Ill, Protein C, Protein S , az-antiplasmin,

8. Plasminogen

9. Lupus anticoagulants

* Not for BI=TTMII analyzer

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/K023309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023309: 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/K023309

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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