510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K875118Substantially Equivalent

Peripheral Vascular Laboratory Assistant Model 101

Bloodflow Laboratory, Inc., Broadview Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875118 is the FDA 510(k) clearance record for PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101, a class II device, cleared for Bloodflow Laboratory, Inc. on under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic). FDA records list one 510(k) clearance for Bloodflow Laboratory, Inc. As of , FDA records show no recalls naming K875118.

Clearance record

Decision date
Received
(153 days to decision)
Product code
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation
21 CFR 870.2780
Device class
Class II
Review panel
Cardiovascular
Applicant
Bloodflow Laboratory, Inc. 4400 Diana Dr., Broadview Heights OH
Third party review
No

Clearances, product code JOM

Trailing 12 months

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

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