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Lc Medical Concepts, Inc.

FDA Regulatory Profile

Lc Medical Concepts, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Lc Medical Concepts, Inc." and its spelling variant "Lc Medical Concepts".

Latest inspection: Feb 25, 2020 · VAI
Latest 510(k): Aug 29, 2016

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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 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	Warning letters
2026	0	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	1	0
2019	0	1
2018	1	0
2017	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.

Recent FDA inspections

2 inspections from Oct 23, 2018 to Feb 25, 2020.

Date	Site	Product	Classification	FEI
Feb 25, 2020	Rochester, NY	Devices	Voluntary Action Indicated (VAI)	3014171842
Oct 23, 2018	Rochester, NY	Devices	No Action Indicated (NAI)	3014171842

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Lc Medical Concepts, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 31, 2019.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3014171842	Rochester, NY	2	Feb 25, 2020

Recent 510(k) clearances

1 510(k) clearance on Aug 29, 2016.

K-Number	Device	Date
K161570	Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam…	Aug 29, 2016

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