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Kbl AG FDA Record

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

Latest inspection NAI · Jun 15, 2023
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 2 Latest Oct 28, 2019

Kbl AG has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kbl AG" is on file.

What these totals cover: FDA records filed under the name "Kbl AG" and its spelling variant "Kbl".

Latest inspection: Jun 15, 2023 · NAI
Latest 510(k): Oct 28, 2019

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	2	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Recent FDA inspections

2 inspections from Sep 2, 2016 to Jun 15, 2023.

Date	Site	Product	Classification	FEI
Jun 15, 2023	Dernbach, Germany	Devices	No Action Indicated (NAI)	3006116732
Sep 2, 2016	Dernbach, Germany	Devices	No Action Indicated (NAI)	3006116732

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 3006116732	Dernbach, Germany	2	Jun 15, 2023

Recent 510(k) clearances

2 510(k) clearances from Sep 15, 2016 to Oct 28, 2019.

K-Number	Device	Date
K191881	KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun	Oct 28, 2019
K151962	KBL Sunlamp Products (= Device Bundling name)	Sep 15, 2016

Kbl AG and the FDA: common questions

Has Kbl AG received an FDA warning letter?

No FDA warning letter addressed to the name "Kbl AG" 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 Kbl AG received an FDA Form 483?

FDA has not published a Form 483 for "Kbl AG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kbl AG?

The most recent FDA inspection on file ended Jun 15, 2023 at Dernbach, Germany and was classified NAI. FDA has 2 inspections of Kbl AG on file.

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