510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990276Substantially Equivalent

Porous Media Dpb30 Series Disposable Pre-Bypass Filter

Pentair Filtration Solutions, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990276 is the FDA 510(k) clearance record for POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER, a class II device, cleared for Porous Media Corp. on under FDA product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass). FDA records list 9 510(k) clearances for Pentair Filtration Solutions, from to . As of , FDA records show no recalls naming K990276.

Clearance record

Decision date
Received
(246 days to decision)
Product code
KRJ Filter, Prebypass, Cardiopulmonary Bypass
Regulation
21 CFR 870.4280
Device class
Class II
Review panel
Cardiovascular
Applicant
Porous Media Corp. 1350 Hammond Rd., St. Paul MN
510(k) summary
Statement
Third party review
No

Clearances, product code KRJ

Trailing 12 months

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

FDA records show no clearances under product code KRJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KRJ, 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