510(k) Report

FDA product code · Hematology

Material, Quality Control, Semen Analysis

NRFClass II21 CFR 864.8625510(k) exempt3 decisions since 20040 recalls

FDA lists NRF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 3 FDA decisions since 2004. No recall names this code.

A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.

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 NRF 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 · NRF

FDA has decided no NRF device since 2007.

Median 510(k) review, days · NRF

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

Recalls per year · NRF

No recall names NRF since 2007.

Adverse event reports per year · NRF

No MAUDE report names NRF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
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—
FIG. 1 — NRF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NRF? 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

Which NRF devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K041240Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc. · 20042generations

What has FDA decided in NRF lately?

  • K042750QC-BeadsBioscreen, Inc. · 2004
  • K041600Qwikcheck-BeadsMedical Electronics Systems, Ltd. · 2004
  • K041240Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc. · 2004

All 3 NRF decisions →

Related product codes

Other codes under 21 CFR 864.8625.

GFS Standards And Controls, Hemoglobin, Normal And…MZG Test, Residual, Wbc In Leukoreduced BloodGJR Control, Red-CellJCN Control, Cell Counter, Normal And AbnormalGJP Control, PlateletGLK Control, HematocritGGL Control, White-CellGGM Control, HemoglobinJPK Mixture, Hematology Quality ControlNRS Control Material, Blood Circulating Epithelial…GLQ Mixture, Control, White-Cell And Red-Cell…