PRECISION FLOW(R) - HELIOX— 510(k) K111640

Name: FDA 510(k) clearance K111640
Creator: U.S. Food and Drug Administration
Published: 2011-10-07

Substantially Equivalent

Vapotherm, Inc.

FDA 510(k) clearance K111640 for PRECISION FLOW(R) - HELIOX, Substantially Equivalent on 2011-10-07. Applicant: Vapotherm, Inc.. Device class: 2.

Clearance details

Applicant: Vapotherm, Inc.
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 2011-06-13
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevensville, MD, US

Download summary PDF View on FDA.gov ↗

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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 K111640

K-number listed on FDA's recall record

Z-1272-2023 — Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOWClass II·Ongoing·Vapotherm·20221216

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111640.

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