510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120532Substantially Equivalent

Getinge 633Hc Steam Sterilizer Air Glide System

Getinge Sourcing, LLC, Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120532 is the FDA 510(k) clearance record for GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM, a class II device, cleared for Getinge Sourcing, LLC on under FDA product code PEC (Sterilizer Automated Loading System). FDA's definition for product code PEC reads: "Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be...". FDA records list 7 510(k) clearances for Getinge Sourcing, LLC, from to . As of , FDA records show no recalls naming K120532.

Clearance record

Decision date
Received
(435 days to decision)
Product code
PEC Sterilizer Automated Loading System
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Getinge Sourcing, LLC 1777 E. Henrietta Rd., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEC

Trailing 12 months

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

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