510(k) · Cleared
Recalled · 2010Hemochron Response
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Technidyne Corp. · KQG Instrument, Coagulation
Cleared on May 3, 1999 as substantially equivalent to K930068 (Technidyne Corp., 1993) after a 213-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- May 3, 1999
- Review
- 213 days
- Class
- Class II
- Product code
- KQG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930068 (1993). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K030818Hemochron Response/SystemInternational Technidyne Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930068 | Hemochron Model 8000/Factor VI Premier Coagulation | Technidyne Corp. | 1993 | — |
| 0 (this device) | K983475 | Hemochron Response | International Technidyne Corp. | 1999 | — |
| +1 | K030818 | Hemochron Response/System | International Technidyne Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 KQG? 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 |
|---|---|---|---|
| * | K930068 | Hemochron Model 8000/Factor VI Premier CoagulationSummary page 2…ls 401 / 801 Deviee Description The IIEMOCIIRON® Response is an upgrade of the HEMOCHRON® Coagulation Instruments, HEMOCHRON® Model 8000 that was approved under 510(k) K930068 and the HEMOCHRON® Models 401 and 801. The HEMOCHRON® Responsc performs the same tests as the predicate HEMOCHRON® Instruments. A… | 1993 |
| * | — | HEMOCHRON® Model 401 Named without a submission number | |
| * | — | HEMOCHRON® Model 801 Named without a submission number |
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 |
|---|---|---|---|
| K030818 | Hemochron Response/System | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2010 | Not classified | Z-1093-2011 | Process control | Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K030818 (International Technidyne Corp., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KQG devicesKQG Instrument, Coagulation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQG
FDA has decided no KQG device since 2007.
Median 510(k) review, days · KQG
Too few KQG 510(k)s in any year since 2007 to give a median.
Recalls per year · KQG
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQG
16in 2010
MAUDE reports naming product code KQG, 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 | 8 |
| 2010 | 0 | — | 1 | 16 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 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 | — | 0 | — |
What is it indicated for?
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays Activated Clotting Time (ACT) — All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) — All HEMOCHRON types Prothrombin Time (PT) — All HEMOCHRON types Thrombin Time (TT) Heparin…
Read the full statement (106 words)
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays
Activated Clotting Time (ACT) — All HEMOCHRON types
Activated Partial Thromboplastin Time (APTT) — All HEMOCHRON types
Prothrombin Time (PT) — All HEMOCHRON types
Thrombin Time (TT)
Heparin Neutralized Thrombin Time (HNTT)
High Dose Thrombin Time (HiTT)
Fibrinogen (FIB)
Protamine Dose Assay (PDA) - All HEMOCHRON types
Heparin Response Time (HRT) - All HEMOCHRON types
Protamine Response Time (PRT) - All HEMOCHRON types
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/K983475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983475: Hemochron Response.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983475
Report an extraction error
Are you the manufacturer?
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