510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031554Substantially Equivalent

S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System

Genzyme Biosurgery, Fall River MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031554 is the FDA 510(k) clearance record for S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM, a class II device, cleared for Genzyme Biosurgery on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 4 510(k) clearances for Genzyme Biosurgery, from to . As of , FDA records show no recalls naming K031554.

Clearance record

Decision date
Received
(67 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Genzyme Biosurgery 600 Airport Rd., Fall River MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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