510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K061848Substantially Equivalent

Hyperspectral Tissue Oxygenation Measurement System, Model Oxy Vu1

Hypermed, Inc., Winchester MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061848 is the FDA 510(k) clearance record for HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1, a class II device, cleared for Hypermed, Inc. on under FDA product code MUD (Oximeter, Tissue Saturation). FDA records list 2 510(k) clearances for Hypermed, Inc., from to . As of , FDA records show no recalls naming K061848.

Clearance record

Decision date
Received
(131 days to decision)
Product code
MUD Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Hypermed, Inc. 11 Mystic Ave., Winchester MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUD

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