SULLIVAN HUMIDAIRE HEATED HUMIDIFIER— 510(k) K971260

Name: FDA 510(k) clearance K971260
Creator: U.S. Food and Drug Administration
Published: 1997-09-04

Substantially Equivalent

Resmed Corp

FDA 510(k) clearance K971260 for SULLIVAN HUMIDAIRE HEATED HUMIDIFIER, Substantially Equivalent on 1997-09-04. Applicant: Resmed Corp. Device class: 2.

Clearance details

Applicant: Resmed Corp
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 1997-04-04
Decision date: 1997-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTT

view all

K262268 — Optiflow Oxygen Kit (AA484J)2026-08-27
K254078 — HVT 2.02026-04-13
K251448 — FL-10000U Respiratory Humidifier2026-01-16
K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP2026-01-14
K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)2025-12-19

More clearances from Resmed Corp

view all

K261360 — EasyCare Tx 22026-08-27
K253553 — Orion2026-06-04
K254104 — ResScan Essentials2026-05-27
K251889 — myAir2026-04-08
K251657 — Personalized Therapy Comfort Settings (PTCS)2025-12-05

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.