FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K Number: K963025
·
Decision Nov 1, 1996
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
23
Review Days
88
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
- SLEEPNET HUMIDIFIER,(84200 PACKAGED)
- K Number
- K963025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sleepnet Corporation
- Date Received
- August 5, 1996
- Decision Date
- November 1, 1996
- 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 Sleepnet Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Jan 15, 2026 | Substantially Equivalent |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Oct 18, 2024 | Substantially Equivalent |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Aug 28, 2024 | Substantially Equivalent |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Jul 10, 2024 | Substantially Equivalent |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | Jun 27, 2024 | Substantially Equivalent |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Jun 15, 2024 | Substantially Equivalent |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | Jan 10, 2022 | Substantially Equivalent |
| K203601 | Innova Nasal Non-Vented Mask | Apr 30, 2021 | Substantially Equivalent |
| K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented | Jul 26, 2019 | Substantially Equivalent |
| K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | Jul 5, 2019 | Substantially Equivalent |