510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K073631Substantially Equivalent

Orqis Extracorporeal Blood Pumping System, Model Bps-100

Orqis Medical Corporation, Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073631 is the FDA 510(k) clearance record for ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100, a class II device, cleared for Orqis Medical Corporation on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list one 510(k) clearance for Orqis Medical Corporation. As of , FDA records show no recalls naming K073631.

Clearance record

Decision date
Received
(184 days to decision)
Product code
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation
21 CFR 870.4360
Device class
Class II
Review panel
Cardiovascular
Applicant
Orqis Medical Corporation 14 Orchard Rd., Suite 100, Lake Forest CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KFM

Trailing 12 months

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

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