510(k) · Cleared
ClearedHemosil Factor Viii Deficient Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GJT Plasma, Coagulation Factor Deficient
Cleared on Jul 8, 2011 as substantially equivalent to K034007 (Instrumentation Laboratory CO, 2004) after a 163-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Jul 8, 2011
- Review
- 163 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K893525 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK893525 Factor Viii Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- 1 generation backK034007 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2004
- This deviceK110237 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2011
- Descendant · cites it directly · 0 of its ownK222831 CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893525 | Factor Viii Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| −1 | K034007 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2004 | — |
| 0 (this device) | K110237 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2011 | — |
| +1 | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 GJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GJT device
- #1 K222831 CRYOcheck Factor VIII Deficient Plasma with VWFscore 6.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K034007 | Hemosil Factor Viii Deficient PlasmaSummary page 1…Substantial Equivalence Information: 1. Predicate device name(s): HemoslL Factor Vill deficient plasma (same name) 2. Predicate 510(k) number(s): K(034007 3. Comparison with predicate: Similarities The applicant, Hemosili Factor VilI deficie… | 2004 |
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 |
|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | 2023 | 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 22 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K222831 (Precision Biologic, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GJT devicesGJT Plasma, Coagulation Factor Deficient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GJT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GJT
444in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GJT
1in 2025
MAUDE reports naming product code GJT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 444 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HemosiL Factor VilI deficient plasma is human plasma, depleted of Factor ViII, which is intended for the in vitro diagnostic quantitative determination of Factor ViII activity in citrated plasma, based on the activated partial thromboplastin time (APrT) assay, on the ACL TOP®0 Family analyzers. HemosIL Factor Vill deficient plasma is indicated for use on patients who are suspected of congenital or acquired deficiency based on the activated partial thromboplastin time (APTT) assay results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110237: Hemosil Factor Viii Deficient Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110237
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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