510(k) · Cleared
ClearedHemosil Routine Control Level 1, Level 2, Level 3 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 Dec 19, 2008 as substantially equivalent to K021023 (Instrumentation Laboratory CO, 2002) and 2 other predicates after an 81-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Dec 19, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002400 (2000). 10 ancestors in all, the oldest K864271 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 1 generation backK021023 Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)Instrumentation Laboratory CO · 2002 · Recalled
- This deviceK082859 Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008
- Descendant · cites it directly · 0 of its ownK110432 Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011 · cites it directly0descendants
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 | K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed) | Instrumentation Laboratory CO | 2002 | 3 |
| 0 (this device) | K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed | Instrumentation Laboratory CO | 2008 | — |
| +1 | 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 |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 | Decided |
|---|---|---|---|
| * | K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)Summary page 1…Control Classification: Class II Product Code: GGN Regulation Number: 21 CFR 864.5425 Identification of Predicate Devices: K021023 HemosIL Normal Control K021022 HemosIL Low Abnormal Control K021024 HemosIL High A… | 2002 |
| * | K021022 | Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)Summary page 1…Product Code: GGN Regulation Number: 21 CFR 864.5425 Identification of Predicate Devices: K021023 HemosIL Normal Control K021022 HemosIL Low Abnormal Control K021024 HemosIL High Abnormal Control Device Descriptions: * The He… | 2002 |
| * | K021024 | Hemosil High Abnormal Control AssayedSummary page 1…r: 21 CFR 864.5425 Identification of Predicate Devices: K021023 HemosIL Normal Control K021022 HemosIL Low Abnormal Control K021024 HemosIL High Abnormal Control Device Descriptions: * The HemosIL Routine Control Level 1 is a lyophilized product… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110432 | Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn | 2011 | 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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.6 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K110432 (Affinity Biologicals, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021023.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems. HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on…
Read the full statement (114 words)
HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082859: Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082859
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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