510(k) · Cleared
Recalled · Class II · 2013Hemochron JR. Citrate Aptt Cuvette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Itc, Inc. · GFO Activated Partial Thromboplastin
Cleared on Jan 24, 2002 as substantially equivalent to K972831 (International Technidyne Corp., 1997) after a 50-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Jan 24, 2002
- Review
- 50 days
- Class
- Class II
- Product code
- GFO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972831 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972831 Hemochron Citrate ApttInternational Technidyne Corp. · 1997
- This deviceK014008 Hemochron JR. Citrate Aptt CuvetteItc, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972831 | Hemochron Citrate Aptt | International Technidyne Corp. | 1997 | — |
| 0 (this device) | K014008 | Hemochron JR. Citrate Aptt Cuvette | Itc, Inc. | 2002 | — |
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 GFO? 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 GFO device
- #1 K253957 HemosIL Silica Clotting Timescore 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K972831 | Hemochron Citrate ApttSummary page 1…modified” Hemochron Jr. Citrate APTT, which is the subject of this special 510(k) is a modification of the predicate Hemochron Jr. Citrate APTT, which was cleared under K972831. Device Description and Technological Characteristics The Hemochron Jr.Citrate APTT test is a self-contained disposable test cu… | 1997 |
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 |
|---|---|---|---|---|
| Dec 19, 2013 | Class II | Z-0937-2014 | Device Design | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All GFO devicesGFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GFO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GFO
Too few GFO 510(k)s in any year since 2007 to give a median.
Recalls per year · GFO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GFO
14in 2025
MAUDE reports naming product code GFO, 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 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 1 | 14 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to
be used in performing a quantitative one-stage Activated Partial Thromboplastin
Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5
units/ml). The test is performed using a citrated whole blood sample on the
Hemochron Jr. microcoagulation instruments. The test is intended for use in point
of care settings.
For In Vitro Diagnostic Use Only
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/K014008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014008: Hemochron JR. Citrate Aptt Cuvette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026