510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972798Substantially Equivalent

Dynemo 3000

Sometec, Inc., Stoneham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972798 is the FDA 510(k) clearance record for DYNEMO 3000, a class II device, cleared for Sometec, Inc. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list one 510(k) clearance for Sometec, Inc. As of , FDA records show no recalls naming K972798.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Sometec, Inc. 92 Montvale Ave., Suite 3150, Stoneham MA
510(k) summary
Summary
Third party review
No

Clearances, product code DPW

Trailing 12 months
3 clearances under product code DPW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260