510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013376Substantially Equivalent

Qflow 500 Perfusion Monitoring System

Hemedex Incorporated, Hopkonton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013376 is the FDA 510(k) clearance record for QFLOW 500 PERFUSION MONITORING SYSTEM, a class II device, cleared for Hemedex Incorporated on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 4 510(k) clearances for Hemedex Incorporated, from to . As of , FDA records show no recalls naming K013376.

Clearance record

Decision date
Received
(209 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Hemedex Incorporated 7 Tiffany Trl., Hopkonton 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