HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010— 510(k) K163283

Name: FDA 510(k) clearance K163283
Creator: U.S. Food and Drug Administration
Published: 2017-09-20

Substantially Equivalent

Hamilton Medical AG

FDA 510(k) clearance K163283 for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010, Substantially Equivalent on 2017-09-20. Applicant: Hamilton Medical AG. Device class: 2.

Clearance details

Applicant: Hamilton Medical AG
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 2016-11-21
Decision date: 2017-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonaduz, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTT

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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 Hamilton Medical AG

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K201306 — HAMILTON-C32021-02-05
K201658 — Hamilton-C62020-12-11
K193228 — Hamilton-G52020-05-04
K181216 — HAMILTON-T1, HAMILTON-C12019-08-02
K161450 — HAMILTON-C32017-04-27

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 →

Recalls naming K163283

K-number listed on FDA's recall record

Z-1385-2022 — HAMILTON-H900 Humidifier, Models: 950001, 950004Class III·Completed·Hamilton Medical AG·20210105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163283.

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