510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052489Substantially Equivalent

Actiheart

Respironics, Inc., Murrysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052489 is the FDA 510(k) clearance record for ACTIHEART, a class II device, cleared for Respironics, Inc. on under FDA product code GWK (Conditioner, Signal, Physiological). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K052489.

Clearance record

Decision date
Received
(15 days to decision)
Product code
GWK Conditioner, Signal, Physiological
Regulation
21 CFR 882.1845
Device class
Class II
Review panel
Neurology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GWK

Trailing 12 months

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

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