FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VersaPAP Positive Airway Pressure (PAP) Device
K Number: K173918
·
Decision Aug 17, 2018
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
9
Review Days
238
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
- VersaPAP Positive Airway Pressure (PAP) Device
- K Number
- K173918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trudell Medical International
- Date Received
- December 22, 2017
- Decision Date
- August 17, 2018
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWF), ordered by most recent decision date.
InSee
FDA 510(k)
FDA Class 2
·Anesthesiology
AllPEP
FDA 510(k)
FDA Class 2
·Anesthesiology
LungTrainer (MD2 & MD3)
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathe+
FDA 510(k)
FDA Class 2
·Anesthesiology
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulsehaler
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Trudell Medical International
| K Number | Device Name | ||
|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Jan 15, 2025 | Substantially Equivalent |
| K203400 | Corrugated tube with mouthpiece accessory | Jun 14, 2021 | Substantially Equivalent |
| K200063 | AeroEclipse* ONE BAN | Jul 17, 2020 | Substantially Equivalent |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Aug 16, 2019 | Substantially Equivalent |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | Jan 11, 2019 | Substantially Equivalent |
| K173825 | MC 300R* Nebulizer | May 2, 2018 | Substantially Equivalent |
| K173367 | MC 300* Nebulizer | Feb 28, 2018 | Substantially Equivalent |
| K150173 | Aerobika OPEP Devive with Manometer | Oct 15, 2015 | Substantially Equivalent |