510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894006Substantially Equivalent

Saniserv Surgical Slush System

Saniserv, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894006 is the FDA 510(k) clearance record for SANISERV SURGICAL SLUSH SYSTEM, a class I device, cleared for Saniserv, Inc. on under FDA product code JRM (Freezer). FDA records list one 510(k) clearance for Saniserv, Inc. As of , FDA records show no recalls naming K894006.

Clearance record

Decision date
Received
(151 days to decision)
Product code
JRM Freezer
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Saniserv, Inc. P.O. Box 41240, Indianapolis IN
Third party review
No

Clearances, product code JRM

Trailing 12 months

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

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