FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEADSTRAP
K Number: K810991
·
Decision Apr 29, 1981
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
5
Applicant Total
172
Review Days
16
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
- HEADSTRAP
- K Number
- K810991
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5560
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respironics, Inc.
- Date Received
- April 13, 1981
- Decision Date
- April 29, 1981
- Product Code
- BTK
- 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 |
|---|---|---|---|
| BTK | Strap, Head, Gas Mask | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTK), ordered by most recent decision date.
GENERAL ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
STRAP, HEAD, GAS MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
HEADSTRAP
FDA 510(k)
FDA Class 1
·Anesthesiology
MEDIPART FACE MASK HEADSTRAP MP-9100
FDA 510(k)
FDA Class 1
·Anesthesiology
HEAD STRAP
FDA 510(k)
FDA Class 1
·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 |