510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254066Substantially Equivalent

Etiometry Platform

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

K254066 is the FDA 510(k) clearance record for Etiometry Platform, a class II device, cleared for Etiometry, Inc. on under FDA product code PPW (Adjunctive Cardiovascular Status Indicator). FDA's definition for product code PPW reads: "The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and...". FDA records list 11 510(k) clearances for Etiometry, Inc., from to . As of , FDA records show no recalls naming K254066.

Clearance record

Decision date
Received
(106 days to decision)
Product code
PPW Adjunctive Cardiovascular Status Indicator
Regulation
21 CFR 870.2200
Device class
Class II
Review panel
Cardiovascular
Applicant
Etiometry, Inc. 770 Legacy Pl., Dedham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PPW

Trailing 12 months
2 clearances under product code PPW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PPW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260