510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021098Substantially Equivalent

Daum-Lectric MRI Drilling Machine

Mri Devices Daum GmbH, Crofton, MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021098 is the FDA 510(k) clearance record for DAUM-LECTRIC MRI DRILLING MACHINE, a class II device, cleared for Mri Devices Daum GmbH on under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece). FDA records list one 510(k) clearance for Mri Devices Daum GmbH. As of , FDA records show no recalls naming K021098.

Clearance record

Decision date
Received
(243 days to decision)
Product code
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation
21 CFR 874.4250
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Mri Devices Daum GmbH P.O. Box 4331, Crofton, MD
510(k) summary
Statement
Third party review
No

Clearances, product code ERL

Trailing 12 months

FDA records hold no clearances under product code ERL in the trailing twelve months.

FDA records show no clearances under product code ERL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ERL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260