510(k) · Cleared

Cleared

Plasmacon N, Plasmacon L-1, Plasmacon L-2

K062306510(k) TraditionalCleared Mar 16, 2007220-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

R2 Diagnostics, Inc. · GGC Control, Plasma, Abnormal

Cleared on Mar 16, 2007 as substantially equivalent to K895262 (Medical Diagnostic Technologies, Inc., 1989) and 2 other predicates after a 220-day review. Its family tree reaches back 1 generation to 1989.

Decided: Mar 16, 2007
Review: 220 days
Class: Class II
Product code: GGC
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K895262 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK895262 Normal Coagulation Control Plasma (NCCP)Medical Diagnostic Technologies, Inc. · 1989
This deviceK062306 Plasmacon N, Plasmacon L-1, Plasmacon L-2R2 Diagnostics, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895262	Normal Coagulation Control Plasma (NCCP)	Medical Diagnostic Technologies, Inc.	1989	—
0 (this device)	K062306	Plasmacon N, Plasmacon L-1, Plasmacon L-2	R2 Diagnostics, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0

FIG. 1 — Lineage of K062306, 1989–2007Source: 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 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K895262	Normal Coagulation Control Plasma (NCCP) Summary page 1 …(per 21 CER section 864.5425) Comparison Device: Normal Coagulation Control Plasma K895262 Abnormal Coagulation Control Plasma Level-…	Medical Diagnostic Technologies, Inc.	1989	—
*	K895260	Abnormal Coagulation Control Plasma-1 (Accp-1) Summary page 1 …K895262 Abnormal Coagulation Control Plasma Level- I K895260 Abnormal Coagulation Control Plasma Level-2…	Medical Diagnostic Technologies, Inc.	1989	—
*	K895261	Abnormal Coagulation Control Plasma-2 (Accp-2) Summary page 1 …Level- I K895260 Abnormal Coagulation Control Plasma Level-2 K895261 Description of the Device Tht P'lasmK on Control Plasma devices contain lyophilized citrated human plasma, for use in the verifi…	Medical Diagnostic Technologies, Inc.	1989	—

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 3 ancestors has a recall.

How does its category compare?

All GGC devices

GGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GGC

1in 2011

2007high 1 (2007) · low 0 (2008)2026

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

2007high 1 (2021) · low 0 (2007)2025

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	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

PlasmaCon N is a human-lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

PlasmaCon L-1I is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062306: Plasmacon N, Plasmacon L-1, Plasmacon L-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062306

Report an extraction error

Are you the manufacturer?

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