510(k) · Cleared
ClearedVital Scientific Aptt, Aptt & Quikcoag Aptt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Scientific N.V. · GFO Activated Partial Thromboplastin
Cleared on Nov 1, 2002 as substantially equivalent to K891337 (Pacific Hemostasis, 1989) after a 134-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 1, 2002
- Review
- 134 days
- Class
- Class II
- Product code
- GFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891337 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891337 Thromboscreen Aptt ReagentPacific Hemostasis · 1989
- This deviceK022021 Vital Scientific Aptt, Aptt & Quikcoag ApttVital Scientific N.V. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891337 | Thromboscreen Aptt Reagent | Pacific Hemostasis | 1989 | — |
| 0 (this device) | K022021 | Vital Scientific Aptt, Aptt & Quikcoag Aptt | Vital Scientific N.V. | 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 |
|---|---|---|---|
| * | K891337 | Thromboscreen Aptt ReagentSummary page 2…safety and effectiveness of APTT has been demonstrated by showing its substantial equivalence to APTT-LS manufactured by Fisher Diagnostics (formerly Pacific Hemostasis) K891337. A correlation study was performed using a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with pa… | 1989 |
| † | K884863 | Electra 900C Automatic Coagulation Timer | 1989 |
| † | K881367 | Acl Systems 100, 200, 300 and 300+ Coagulation Sys | 1988 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K891337.
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 Vital Scientific APTT is an iiz-litro diagnostic reagent intended for use in a nianual method in a clinical laboratory for the perfomiance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022021 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022021: Vital Scientific Aptt, Aptt & Quikcoag Aptt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022021
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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