FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Astral 100/150
K Number: K152068
·
Decision May 13, 2016
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
103
Review Days
294
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
- Astral 100/150
- K Number
- K152068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resmed, Ltd.
- Date Received
- July 24, 2015
- Decision Date
- May 13, 2016
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBK), ordered by most recent decision date.
Evita (V800); Evita (V600)
FDA 510(k)
FDA Class 2
·Anesthesiology
Inbentus Versatile
FDA 510(k)
FDA Class 2
·Anesthesiology
VPAP Pediatric Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Vivo 45 LS
FDA 510(k)
FDA Class 2
·Anesthesiology
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
FDA 510(k)
FDA Class 2
·Anesthesiology
SV600, SV800 Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Resmed, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K183512 | Moore Park Mask | May 7, 2019 | Substantially Equivalent |
| K180497 | Scone Mask | Jun 15, 2018 | Substantially Equivalent |
| K172875 | Astral 100/150 | Apr 26, 2018 | Substantially Equivalent |
| K170924 | AirFit F20 | Jan 3, 2018 | Substantially Equivalent |
| K171212 | AirFit N20 | Sep 28, 2017 | Substantially Equivalent |
| K161492 | Juno VPAP ST-A | Jan 19, 2017 | Substantially Equivalent |
| K160836 | Menai System | Dec 15, 2016 | Substantially Equivalent |
| K161978 | AirFit N20 | Nov 17, 2016 | Substantially Equivalent |
| K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV | Sep 9, 2016 | Substantially Equivalent |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Sep 9, 2016 | Substantially Equivalent |