510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K161411Substantially Equivalent

Care Cycle Connect Application

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

K161411 is the FDA 510(k) clearance record for Care Cycle Connect Application, a class II device, cleared for Respironics, Inc. on under FDA product code MOD (Accessory To Continuous Ventilator (Respirator)). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K161411.

Clearance record

Decision date
Received
(273 days to decision)
Product code
MOD Accessory To Continuous Ventilator (Respirator)
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOD

Trailing 12 months
3 clearances under product code MOD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260