510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K011427Substantially Equivalent

Mbi Pd-103 Sl; Mbi Pd-103 Sh

Mills Biopharmaceuticals, Inc., Oklahoma City OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011427 is the FDA 510(k) clearance record for MBI PD-103 SL; MBI PD-103 SH, a class II device, cleared for Mills Biopharmaceuticals, Inc. on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list one 510(k) clearance for Mills Biopharmaceuticals, Inc. As of , FDA records show no recalls naming K011427.

Clearance record

Decision date
Received
(115 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Mills Biopharmaceuticals, Inc. 120 NE 26th St., Oklahoma City OK
510(k) summary
Summary
Third party review
No

Clearances, product code KXK

Trailing 12 months
1 clearance under product code KXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260