510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875275Substantially Equivalent

Winthrop Pharmaceuticals Contrast Media Warmer

Sterling Drug, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875275 is the FDA 510(k) clearance record for WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER, a class I device, cleared for Sterling Drug, Inc. on under FDA product code JTQ (Bath, Incubators/Water, All). FDA records list 9 510(k) clearances for Sterling Drug, Inc., from to . As of , FDA records show no recalls naming K875275.

Clearance record

Decision date
Received
(34 days to decision)
Product code
JTQ Bath, Incubators/Water, All
Regulation
21 CFR 866.2540
Device class
Class I
Review panel
Microbiology
Applicant
Sterling Drug, Inc. 90 Park Ave., New York NY
Third party review
No

Clearances, product code JTQ

Trailing 12 months

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

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