510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152258Substantially Equivalent

T3 Software

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

K152258 is the FDA 510(k) clearance record for T3 Software, a class II device, cleared for Etiometry, Inc. on under FDA product code PLB (Multivariate Vital Signs Index). FDA's definition for product code PLB reads: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs". FDA records list 11 510(k) clearances for Etiometry, Inc., from to . As of , FDA records show no recalls naming K152258.

Clearance record

Decision date
Received
(233 days to decision)
Product code
PLB Multivariate Vital Signs Index
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Etiometry, Inc. 119 Braintree St. Suite 210, Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLB

Trailing 12 months

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

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