510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170021Unknown

SEM Scanner (Model 200)

Bruin Biometrics, LLC, Los Angeles CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170021 is the FDA 510(k) clearance record for SEM Scanner (Model 200), a class I device, cleared for Bruin Biometrics, LLC on under FDA product code QEF (Pressure Ulcer Management Tool). FDA's definition for product code QEF reads: "A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for...". FDA records list one 510(k) clearance for Bruin Biometrics, LLC. As of , FDA records show no recalls naming DEN170021.

Clearance record

Decision date
Received
(626 days to decision)
Product code
QEF Pressure Ulcer Management Tool
Regulation
21 CFR 876.2100
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Bruin Biometrics, LLC 10960 Wilshire Blvd., Suite 950, Los Angeles CA
Third party review
No

Clearances, product code QEF

Trailing 12 months

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

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