510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K974180Substantially Equivalent

Steri-Tamp

Pharmacy, Inc., New Port Riche FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974180 is the FDA 510(k) clearance record for STERI-TAMP, a class II device, cleared for Pharmacy, Inc. on under FDA product code KPE (Container, I.V.). FDA records list one 510(k) clearance for Pharmacy, Inc. As of , FDA records show no recalls naming K974180.

Clearance record

Decision date
Received
(110 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Pharmacy, Inc. 3234 Ella Ln., New Port Riche FL
510(k) summary
Summary
Third party review
No

Clearances, product code KPE

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