510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K140736Substantially Equivalent

Sterisafe Hp Table-Top Steam Sterilizer

Milton E Pedrazzi D.D.S., Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K140736 is the FDA 510(k) clearance record for STERISAFE HP TABLE-TOP STEAM STERILIZER, a class II device, cleared for Milton E Pedrazzi D.D.S., Inc. on under FDA product code FLE (Sterilizer, Steam). FDA records list one 510(k) clearance for Milton E Pedrazzi D.D.S., Inc. As of , FDA records show no recalls naming K140736.

Clearance record

Decision date
Received
(302 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Milton E Pedrazzi D.D.S., Inc. 6501 Crown Blvd., Suite 102, San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE 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 FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260