510(k) · Cleared

Cleared

Fibron-1, Fibron-4, Quikcoag, Fibron

K021976510(k) TraditionalCleared Oct 25, 2002130-day reviewClass II21 CFR 864.5400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vital Scientific N.V. · KQG Instrument, Coagulation

Cleared on Oct 25, 2002 as substantially equivalent to K884863 (Medical Laboratory Automation Systems, Inc., 1989) after a 130-day review. Its family tree reaches back 1 generation to 1989.

Decided: Oct 25, 2002
Review: 130 days
Class: Class II
Product code: KQG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K884863 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK884863 Electra 900C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc. · 1989
This deviceK021976 Fibron-1, Fibron-4, Quikcoag, FibronVital Scientific N.V. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K884863	Electra 900C Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	1989	—
0 (this device)	K021976	Fibron-1, Fibron-4, Quikcoag, Fibron	Vital Scientific N.V.	2002	—

FIG. 1 — Lineage of K021976, 1989–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K884863	Electra 900C Automatic Coagulation Timer Summary page 2 …formance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT). Substantial Equivalence: The Fibron-1 is comparable to the MLA-9OOC (K884863) and the ACL 100 (K88J 367). The instruments have a similar intended use for in-vitro diagnostic coagulation testing in the clini…	Medical Laboratory Automation Systems, Inc.	1989	—
Kept off the family tree	K883367	FDA’s K883367 is Calf Serum, Catalog NO. 110-1125 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	J R Scientific	1988	—

Also cleared against K884863: 5 other devices →

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.
5 other devices also cite its predicate K884863.

How does its category compare?

All KQG devices

KQG 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

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KQG

16in 2010

2007high 16 (2010) · low 0 (2007)2025

MAUDE reports naming product code KQG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	8
2010	—	1	16
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021976 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021976: Fibron-1, Fibron-4, Quikcoag, Fibron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021976

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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