Puritan-Bennett Cascade I Series Humidifier Modification
FDA 510(k) K936000 · Puritan Bennett Corp.
510(k) numberK936000
Submission
- Device name
- Puritan-Bennett Cascade I Series Humidifier Modification
- Applicant
- Puritan Bennett Corp.
Carlsbad, CA, US - Received
- December 15, 1993
- Decision date
- August 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
Other 510(k)s with product code BTT
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| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K063650 | Ventilator with Respiratory Mechanics, Model 840CBK · Special | 02/15/2007SE |
| K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionCBK · Traditional | 04/04/2006SE |
| K023225 | Puritan Bennett Dataflow Data Management SoftwareBZG · Abbreviated | 12/18/2002SE |
| K022103 | Puritan-Bennett 700 Renaissance II Spirometry SystemBZG · Special | 09/27/2002SE |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionCBK · Special | 08/13/2002ST |
| K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionCBK · Traditional | 10/20/2000ST |
| K002001 | Breeze Sleepgear with DreamsealBZD · Special | 09/06/2000SE |
| K993071 | Puritan-Bennett Ventilator System with Et/Tracheostomy Tube Compensation, TC, Option…CBK · Special | 11/24/1999ST |
| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemBYJ · Special | 10/22/1999SE |
| K993088 | Puritan-Bennett Aeris 590 Oxygen Concentrator with OciCAW · Special | 10/08/1999SE |
Questions and answers
When was Puritan-Bennett Cascade I Series Humidifier Modification cleared by the FDA?
Puritan-Bennett Cascade I Series Humidifier Modification (K936000) received a 510(k) decision of Substantially Equivalent on August 15, 1994, 243 days after the submission was received.
What is the product code of K936000?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.