510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K932251Substantially Equivalent

Rotator;male-Male, Male-Female

Merit Medical Systems, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932251 is the FDA 510(k) clearance record for ROTATOR;MALE-MALE, MALE-FEMALE, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code DTR (Heat-Exchanger, Cardiopulmonary Bypass). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K932251.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DTR Heat-Exchanger, Cardiopulmonary Bypass
Regulation
21 CFR 870.4240
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical Systems, Inc. 79 W. 4500 S., Suite 9, Salt Lake City UT
510(k) summary
Summary
Third party review
No

Clearances, product code DTR

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