510(k) · Cleared

Recalled · Class III · 2022

Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator

K051472510(k) TraditionalCleared Dec 23, 2005203-day reviewClass II21 CFR 864.5425Recalls 4

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

Hyphen Biomed · GGN Plasma, Coagulation Control

Cleared on Dec 23, 2005 as substantially equivalent to K030965 (Instrumentation Laboratory CO, 2003) and 3 other predicates after a 203-day review. Its family tree reaches back 2 generations to 2000. It has been recalled 4 times.

Decided: Dec 23, 2005
Review: 203 days
Class: Class II
Product code: GGN
Recalls: 4
Predicates: 4

Its longest line of descent runs back 2 generations to K002400 (2000). 7 ancestors in all, the oldest K812424 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
1 generation backK030965 Control Plasma LMW HeparinInstrumentation Laboratory CO · 2003
This deviceK051472 Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin…Hyphen Biomed · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002400	Modification of Acl Advance	Instrumentation Laboratory CO	2000	2
−1	K030965	Control Plasma LMW Heparin	Instrumentation Laboratory CO	2003	—
0 (this device)	K051472	Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh…	Hyphen Biomed	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1984	1	0
1995	1	0
2003	1	0
2004	1	0

FIG. 1 — Lineage of K051472, 2000–2005Source: 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 GGN? 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? (4)

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
*	K030965	Control Plasma LMW Heparin Summary page 1 …WH Low Control Plasma GGN for Biophen UFH Control Plasma Predicate Device Information: Biophen LMWH & LMWH Low Control Plasma: Control Plasma LMW Heparin (K030965) Biophen UFH Control Plasma: Heparin Control (K943520) - pJvf Description of the Devicelintended use: Biophen LMWH, LMWH Low an…	Instrumentation Laboratory CO	2003	—
*	K943520	Heparin Control Kit Summary page 1 …H Control Plasma Predicate Device Information: Biophen LMWH & LMWH Low Control Plasma: Control Plasma LMW Heparin (K030965) Biophen UFH Control Plasma: Heparin Control (K943520) - pJvf Description of the Devicelintended use: Biophen LMWH, LMWH Low and UFH Control Plasma is an in vitro diagnostic quality…	American Bioproducts Co.	1995	—
*	K030964	Calibration Plasma LMW Heparin Summary page 3 …r Biophen UFH Calibrator Classification Name: Calibrator, Secondary Classification: Class II Regulation#: 862.1150 Product Code: JIT Predicate Device Information: K030964 Calibration Plasma LMW Heparin K042941 Heparin Calibrators & Controls Device intended use: Biophen Heparin Calibrator is a set…	Instrumentation Laboratory CO	2003	—
*	K042941	Dade Behring Heparin Calibrator and Controls Summary page 3 …n Name: Calibrator, Secondary Classification: Class II Regulation#: 862.1150 Product Code: JIT Predicate Device Information: K030964 Calibration Plasma LMW Heparin K042941 Heparin Calibrators & Controls Device intended use: Biophen Heparin Calibrator is a set of calibration plasmas for Heparin (UFH…	Dade Behring, Inc.	2004	—

Also cleared against K030965: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 28, 2022	Class III	Z-1743-2022	Under Investigation by firm	Incorrect product labeling was included in the package.
Mar 19, 2019	Class III	Z-1189-2019	Error in labeling	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Mar 19, 2019	Class III	Z-1190-2019	Error in labeling	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Mar 19, 2019	Class III	Z-1188-2019	Error in labeling	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
1 of the 7 ancestors has a recall of any class.
2 other devices also cite its predicate K030965.

How does its category compare?

All GGN devices

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

FDA decisions per year · GGN

4in 2017

2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGN

4in 2018

2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, 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	3	47	0	0
2008	1	—	0	0
2009	2	—	0	37
2010	3	23	4	17
2011	2	—	1	30
2012	1	—	0	10
2013	3	441	3	9
2014	2	—	0	5
2015	0	—	0	10
2016	2	—	0	9
2017	4	96	0	11
2018	0	—	0	4
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	—	2	—

What is it indicated for?

Biophen Low Molecular Weight Heparin (LMWH), Low Molecular Weight Heparin Low (LMWH Low) and Unfractionated Heparin (UFH) control are set of control plasmas for the quality control of Low Molecular weight Heparin(LMWH) and Unfractionated Heparin(UFH) measurements using anti Xa colorimetric assays (Biophen Heparin 3 & 6).

These control plasmas are within the usual therapeutic range recommended for the low molecular weight heparin (LMWH) and Unfractionated Heparin (UFH).

Biophen Heparin & Unfractionated heparin (UFH) Calibrators are set of calibration plasmas for the measurement of Low molecular weight heparin (LMWH) and Unfractionated heparin, using anti-Xa colorimetric assays.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051472: Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051472

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