← Product Code [BTT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT) · K914686

# THERMO-FLOW SET (K914686)

_Inhalation Plastics · BTT · Apr 15, 1992 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K914686

## Device Facts

- **Applicant:** Inhalation Plastics
- **Product Code:** [BTT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT.md)
- **Decision Date:** Apr 15, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5450
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K914686](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K914686)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com