510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050313Substantially Equivalent

Bis Srs (Semi-Resuable Sensor)

Aspect Medical Systems, Inc., Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050313 is the FDA 510(k) clearance record for BIS SRS (SEMI-RESUABLE SENSOR), a class I device, cleared for Aspect Medical Systems, Inc. on under FDA product code GWY (Pinwheel). FDA records list 25 510(k) clearances for Aspect Medical Systems, Inc., from to . As of , FDA records show no recalls naming K050313.

Clearance record

Decision date
Received
(15 days to decision)
Product code
GWY Pinwheel
Regulation
21 CFR 882.1750
Device class
Class I
Review panel
Neurology
Applicant
Aspect Medical Systems, Inc. 141 Needham St., Newton MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GWY

Trailing 12 months

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

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