FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRONICS HEATED HUMIDIFIER
K Number: K012633
·
Decision Feb 28, 2002
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
172
Review Days
199
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RESPIRONICS HEATED HUMIDIFIER
- K Number
- K012633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- August 13, 2001
- Decision Date
- February 28, 2002
- Product Code
- BTT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTT), ordered by most recent decision date.
HVT 2.0
FDA 510(k)
FDA Class 2
·Anesthesiology
FL-10000U Respiratory Humidifier
FDA 510(k)
FDA Class 2
·Anesthesiology
Laboratorios Biogalenic Sterile Water for Inhalation, USP
FDA 510(k)
FDA Class 2
·Anesthesiology
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
FDA 510(k)
FDA Class 2
·Anesthesiology
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
FDA 510(k)
FDA Class 2
·Anesthesiology
Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Respironics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | Dec 30, 2024 | Substantially Equivalent |
| K231313 | Therapy Mask 3100 NC/SP | Jul 28, 2023 | Substantially Equivalent |
| K210844 | DreamWear Silicone Pillows Mask | Aug 24, 2021 | Substantially Equivalent |
| K210386 | Magneto Nasal Mask | Jul 12, 2021 | Substantially Equivalent |
| K202142 | Sleepware G3 | Oct 29, 2020 | Substantially Equivalent |
| K201439 | Ventilator, Non-continuous (Respirator) | Sep 25, 2020 | Substantially Equivalent |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Jul 10, 2020 | Substantially Equivalent |
| K183226 | Care Orchestrator Essence | Oct 18, 2019 | Substantially Equivalent |
| K183625 | SomnaPatch | Oct 18, 2019 | Substantially Equivalent |
| K181166 | Trilogy Evo | Jul 18, 2019 | Substantially Equivalent |