FDA product code · Hematology

Protamine Sulphate

Name: FDA decisions, review times, recalls and adverse event reports for product code GFT
Creator: 510(k) Report

GFTClass II21 CFR 864.7525510(k) required2 decisions since 19910 recalls

2 FDA decisions since 1991. No recall names this code.

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

FIG. A — Illustration, hematology panel

Twenty years of GFT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · GFT

FDA has decided no GFT device since 2007.

Median 510(k) review, days · GFT

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

Recalls per year · GFT

No recall names GFT since 2007.

Adverse event reports per year · GFT

No MAUDE report names GFT since 2007.

View these four charts as a table

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

FIG. 1 — GFT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GFT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 864.7525.

KFF Assay, Heparin JBR Test, Heparin Neutralization

Protamine Sulphate

What has FDA decided in GFT lately?

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