510(k) · Cleared

Recalled · Class II · 2013

Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)

K021022510(k) TraditionalCleared May 14, 200246-day reviewClass II21 CFR 864.5425Recalls 3

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

Instrumentation Laboratory CO · GGN Plasma, Coagulation Control

Cleared on May 14, 2002 as substantially equivalent to K931117 (Instrumentation Laboratory CO, 1994) and 4 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it. It has been recalled 3 times.

Decided: May 14, 2002
Review: 46 days
Class: Class II
Product code: GGN
Recalls: 3
Predicates: 5

Its longest line of descent runs back 1 generation to K864271 (1986). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK864271 IL Test 84673-30 Chromogenics Control PlasmaInstrumentation Laboratory CO · 1986
This deviceK021022 Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal…Instrumentation Laboratory CO · 2002
Descendant · cites it directly · 1 of its ownK082859 Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008
Descendant · 2 generations on · 0 of its ownK110432 Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all

K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008 · cites it directly1descendant
K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864271	IL Test 84673-30 Chromogenics Control Plasma	Instrumentation Laboratory CO	1986	—
0 (this device)	K021022	Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2…	Instrumentation Laboratory CO	2002	—
+1	K082859	Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed	Instrumentation Laboratory CO	2008	—
+2	K110432	Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn	Affinity Biologicals, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	1	0
1994	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0

FIG. 1 — Lineage of K021022, 1986–2011Source: 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? (5)

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
*	K931117	Assess (TM) Low Abnormal Control Summary page 1 …rol Product Code: 81GGN Regulation Number: 21 CFR 864.5425 Classification: Class 11 Identification of Predicate Device(s): 510(k) No. Predicate Device(s) Analytes K931117 \| Assess™ Low Abnormal Control Prothrombin Time (PT) Activated Partial Thromboplastin (APTT) K864271 \| IL Test™ Abnormal Chromoge…	Instrumentation Laboratory CO	1994	—
*	K864271	IL Test 84673-30 Chromogenics Control Plasma Summary page 1 …ion of Predicate Device(s): 510(k) No. Predicate Device(s) Analytes K931117 \| Assess™ Low Abnormal Control Prothrombin Time (PT) Activated Partial Thromboplastin (APTT) K864271 \| IL Test™ Abnormal Chromogenic Control Plasma \| Antithrombin Level 1 K912711 \| IL Test™ Protein C Control Plasma Protein C (comp…	Instrumentation Laboratory CO	1986	—
*	K912711	IL Test Proclot Assay Stystem Summary page 1 …Assess™ Low Abnormal Control Prothrombin Time (PT) Activated Partial Thromboplastin (APTT) K864271 \| IL Test™ Abnormal Chromogenic Control Plasma \| Antithrombin Level 1 K912711 \| IL Test™ Protein C Control Plasma Protein C (component of IL Test™ ProClot kit) K930327 \| IL Test™ Protein S Control Plasma Pro…	Instrumentation Laboratory CO	1991	—
*	K930327	IL Test (TM) Protein S Summary page 1 …) K864271 \| IL Test™ Abnormal Chromogenic Control Plasma \| Antithrombin Level 1 K912711 \| IL Test™ Protein C Control Plasma Protein C (component of IL Test™ ProClot kit) K930327 \| IL Test™ Protein S Control Plasma Protein S (component of IL Test™ Protein S kit) K000679 \| ThromboScreen Abnormal Thrombin Tim…	Instrumentation Laboratory CO	1993	—
*	K000679	Thrombostrate Control Plasmas Summary page 1 …Test™ Protein C Control Plasma Protein C (component of IL Test™ ProClot kit) K930327 \| IL Test™ Protein S Control Plasma Protein S (component of IL Test™ Protein S kit) K000679 \| ThromboScreen Abnormal Thrombin Time Control \| Thrombin Time Description of the Device/Intended Use(s): HemosIL Low Abnormal…	Pacific Hemostasis	2000	—

Also cleared against K931117: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082859	Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed	Instrumentation Laboratory CO	2008	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 15, 2013	Class II	Z-0516-2014	No Marketing Application	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Nov 15, 2013	Class II	Z-0515-2014	No Marketing Application	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Nov 15, 2013	Class II	Z-0514-2014	No Marketing Application	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 5 ancestors has a recall.
Of its descendants, K082859 (Instrumentation Laboratory CO, 2008) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K931117.

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?

HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.

Values for all analytes are in the low abnormal range.

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/K021022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021022: Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021022

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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