510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944293Substantially Equivalent

Sabratek Sabsil Sets

Sabratek Corp., Niles IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944293 is the FDA 510(k) clearance record for SABRATEK SABSIL SETS, a class II device, cleared for Sabratek Corp. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 7 510(k) clearances for Sabratek Corp., from to . As of , FDA records show no recalls naming K944293.

Clearance record

Decision date
Received
(202 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Sabratek Corp. 5601 W. Howard, Niles IL
510(k) summary
Statement
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260