STERILE WATER FOR INHALATION USP 2D0799— 510(k) K851940

Name: FDA 510(k) clearance K851940
Creator: U.S. Food and Drug Administration
Published: 1985-06-20

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K851940 for STERILE WATER FOR INHALATION USP 2D0799, Substantially Equivalent on 1985-06-20. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 1985-05-03
Decision date: 1985-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, 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 Travenol Laboratories, S.A.

view all

K874181 — BAXTER BEDSIDE SYSTEM1988-02-22
K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE1987-11-05
K873873 — RESUBMITTED MICRON TRANSFUSION FILTER1987-10-22
K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)1987-10-20
K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M13091987-10-13

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.