FDA product code · Hematology

Sparse Sample Pk Profile And Dosing Software

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

PHYClass II21 CFR 868.1890510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

To estimate PK profile and dosing calculation.

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 PHY 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 · PHY

FDA has decided no PHY device since 2007.

Median 510(k) review, days · PHY

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

Recalls per year · PHY

No recall names PHY since 2007.

Adverse event reports per year · PHY

1in 2016

2007high 1 (2016) · low 0 (2007)2025

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

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	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in PHY? 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

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