510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831286Substantially Equivalent

Ultipore Prebypass Plus Filter

Pall Biomedical Products Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831286 is the FDA 510(k) clearance record for ULTIPORE PREBYPASS PLUS FILTER, a class II device, cleared for Pall Biomedical Products Co. on under FDA product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass). FDA records list 28 510(k) clearances for Pall Biomedical Products Co., from to . As of , FDA records show no recalls naming K831286.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KRJ Filter, Prebypass, Cardiopulmonary Bypass
Regulation
21 CFR 870.4280
Device class
Class II
Review panel
Cardiovascular
Applicant
Pall Biomedical Products Co. 803 N. Front St. Suite 3, Mchenry IL
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