510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250885Substantially Equivalent

Ceftobiprole BPR 5 µg Disc

Liofilchem S.r.l., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K250885 is the FDA 510(k) clearance record for Ceftobiprole BPR 5 µg Disc, a class II device, cleared for Liofilchem, Inc. on under FDA product code JTN (Susceptibility Test Discs, Antimicrobial). FDA records list 38 510(k) clearances for Liofilchem, Inc., from to . As of , FDA records show no recalls naming K250885.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JTN Susceptibility Test Discs, Antimicrobial
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Liofilchem, Inc. 465 Waverley Oakes Rd., Waltham MA
510(k) summary
Statement
Third party review
No

Clearances, product code JTN

Trailing 12 months
6 clearances under product code JTN in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JTN, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20262
August 20261
September 20260
October 20260