510(k) · Cleared
Recalled · Class II · 2013Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GGN Plasma, Coagulation Control
Cleared on May 14, 2002 as substantially equivalent to K002400 (Instrumentation Laboratory CO, 2000) after a 46-day review. Its family tree reaches back 1 generation to 2000. 3 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
- 1
Its longest line of descent runs back 1 generation to K002400 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- This deviceK021023 Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)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 · cites it directly · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
- 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 3 of 3 · See all- K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008 · cites it directly1descendant
- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd. · 2018 · cites it directly0descendants
- 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 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| 0 (this device) | K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed) | Instrumentation Laboratory CO | 2002 | — |
| +1 | K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed | Instrumentation Laboratory CO | 2008 | — |
| +1 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
| +2 | K110432 | Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn | Affinity Biologicals, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 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 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
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 |
|---|---|---|---|
| * | K002400 | Modification of Acl AdvanceSummary page 1…on Name(s): Common Name Plasma Coagulation Control Product Code 81GGN Regulation Number 21 CFR 864.5425 Classification Class II Identification of Predicate Device(s): K 002400 Assess™ Normal Control NOTE: Control was 510(k) cleared as part of analyzer systems, most recently the ACL Advance. Description… | 2000 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
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 Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.
Values for all analytes are within the normal 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/K021023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021023: Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021023
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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