510(k) · Cleared
ClearedVALIDATE Heparin Calibration Verification/Linearity Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Company, LLC · GGN Plasma, Coagulation Control
Cleared on Mar 16, 2017 as substantially equivalent to K090209 (Instrumentation Laboratory CO, 2009) after a 93-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 16, 2017
- Review
- 93 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935212 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- 2 generations backK980242 IL Test HeparinInstrumentation Laboratory CO · 1998 · Recalled
- 1 generation backK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009 · Recalled
- This deviceK163498 VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| −2 | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | 1 |
| −1 | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls | Instrumentation Laboratory CO | 2009 | 5 |
| 0 (this device) | K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 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 |
|---|---|---|---|
| * | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsSummary page 4…Linearity Test Kit Review Panel: Hematology (81) Regulation Number: 21 CFR 864.5425 Product Code: GGN Regulatory Class: Class Il C. Predicate Device Identification: K090209, HemosIL® Liquid LMW/UF Heparin Controls, Instrumentation Laboratory D. Candidate Device description: Each VALIDATE® Heparin Cal… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K090209.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
VALIDATE® Heparin Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on the IL ACL TOP® analyzer.
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/K163498 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163498: VALIDATE Heparin Calibration Verification/Linearity Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163498
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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