What law does NO 510(K) cite?

FDA's refusal charge table cites section 801(a)(3) of the FD&C Act (502(o) misbranding) for NO 510(K), and classifies the charge as 502(o) misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most NO 510(K) refusals?

As of October 26, 2026, the countries with the most NO 510(K) refusal lines are China (1) and United Kingdom (1). The full list with links is in the table on this page.

Is there an FDA import alert for NO 510(K)?

SupplierRadar found no food import alert whose charge section names NO 510(K). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

FDA refusal charge

FDA refusal charge NO 510(K)

Is a post 1976 device for which a Section 510(k)application does not appear to have been determined…

NO 510(K) is the FDA import refusal charge for is a post 1976 device for which a Section 510(k)application does not appear to have been determined…; it cites section 801(a)(3) of the FD&C Act (502(o) misbranding). FDA recorded it on 2 refused shipment lines from 2 countries between October 2016 and April 15, 2026, most often for meal replacements from China.

Data from FDA public records, last checked October 26, 2026.

2
refused shipment lines carry this charge: 2
countries of origin: 0
import alerts name this charge

What NO 510(K) means

SupplierRadar has not written a plain-English version of NO 510(K) yet. FDA's own statement is quoted below.

FD&C Act section: 801(a)(3)
Classification: 502(o) misbranding

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

NO 510(K) · 801(a)(3); 502(o) MisbrandingFDA reference table (CSV)

Countries with the most NO 510(K) refusals

Shipment lines carrying NO 510(K), by country of origin.

NO 510(K) refusal lines by country
Country	Lines	Share of NO 510(K)
China	1	50%
United Kingdom	1	50%

Product categories with the most NO 510(K) refusals

NO 510(K) refusal lines by product category
Category	Lines	Share of NO 510(K)
Dietary Conventional Foods and Meal Replacements	1	50%
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties	1	50%

Latest NO 510(K) refusals

The 2 most recent refused lines, through April 15, 2026, each with its FDA source.

Latest FDA refusals carrying NO 510(K)
Date	Firm	Product	Charges
Apr 15, 2026	Live Wellness LimitedGlasgow, United Kingdom	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	NOT LISTED FRNMFGREG REGISTERED+1	Source
Jul 11, 2017	Ssg (China)Beijing, China	Foods with supplemental nutrients added, with or without artifical sweetners	NOT LISTED FRNMFGREG NO 510(K)	Source

Questions about NO 510(K)

What does NO 510(K) mean on an FDA refusal?: NO 510(K) is the refusal charge “Is a post 1976 device for which a Section 510(k)application does not appear to have been determined…”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.”
What law does NO 510(K) cite?: FDA's refusal charge table cites section 801(a)(3) of the FD&C Act (502(o) misbranding) for NO 510(K), and classifies the charge as 502(o) misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most NO 510(K) refusals?: As of October 26, 2026, the countries with the most NO 510(K) refusal lines are China (1) and United Kingdom (1). The full list with links is in the table on this page.
Is there an FDA import alert for NO 510(K)?: SupplierRadar found no food import alert whose charge section names NO 510(K). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.