510(k) Report

510(k) · Cleared

Cleared

Aca Fibrinogen Calibrator

K812628510(k) TraditionalCleared Nov 24, 198170-day reviewClass II21 CFR 864.7340

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

E.I. Dupont DE Nemours & Co., Inc. · GFX Fibrinogen Standard

Cleared on Nov 24, 1981 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 24, 1981
Review
70 days
Class
Class II
Product code
GFX
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K812628Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All GFX devices

GFX Fibrinogen Standard: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFX

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GFX

Too few GFX 510(k)s in any year since 2007 to give a median.

Recalls per year · GFX

No recall names GFX since 2007.

Adverse event reports per year · GFX

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from E.I. Dupont DE Nemours & Co., Inc.

253 FDA decisions under this applicant name. See the company

  • K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayE.I. Dupont DE Nemours & Co., Inc. · 1996
  • K953724Cronex Radiation Therapy CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K953725Cronex Radiation Therapy Verification CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K951441Dupont Aca Digoxin (DGN a) MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K950137Urine Barbiturates Screen Flex (TM) Reagent CartridgeE.I. Dupont DE Nemours & Co., Inc. · 1995

Recent decisions in GFX

The GFX category page

  • K072304Fibrinogen Calibrator KitDade Behring, Inc. · 2007
  • K994341Fibrinogen Calibrator KitDade Behring, Inc. · 2000

https://510kreport.com/device/K812628 · printed Nov 4, 2026

Cite this page

510(k) Report. “K812628: Aca Fibrinogen Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K812628

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026