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Ultralinq Healthcare Solutions, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Mar 11, 2021
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 1 Latest Jul 17, 2015

Ultralinq Healthcare Solutions, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Ultralinq Healthcare Solutions, Inc." is on file.

What these totals cover: FDA records filed under the name "Ultralinq Healthcare Solutions, Inc." and its spelling variant "Ultralinq Healthcare Solutions".

Latest inspection: Mar 11, 2021 · VAI
Latest 510(k): Jul 17, 2015

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Ultralinq Healthcare Solutions, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Ultralinq Healthcare Solutions, Inc.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

2 inspections from Jan 30, 2018 to Mar 11, 2021.

Date	Site	Product	Classification	FEI
Mar 11, 2021	Morrisville, NC	Devices	Voluntary Action Indicated (VAI)	3014174753
Jan 30, 2018	Morrisville, NC	Devices	Voluntary Action Indicated (VAI)	3014174753

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3014174753	Morrisville, NC	2	Mar 11, 2021

Recent 510(k) clearances

1 510(k) clearance on Jul 17, 2015.

K-Number	Device	Date
K143176	UltraLinq	Jul 17, 2015

Ultralinq Healthcare Solutions, Inc. and the FDA: common questions

Has Ultralinq Healthcare Solutions, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ultralinq Healthcare Solutions, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Ultralinq Healthcare Solutions, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Ultralinq Healthcare Solutions, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Ultralinq Healthcare Solutions, Inc.?

The most recent FDA inspection on file ended Mar 11, 2021 at Morrisville, NC and was classified VAI. FDA has 2 inspections of Ultralinq Healthcare Solutions, Inc. on file.

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