FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
K Number: K091111
·
Decision Dec 2, 2009
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
45
Review Days
229
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
- RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
- K Number
- K091111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Industries, Inc.
- Date Received
- April 17, 2009
- Decision Date
- December 2, 2009
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAF), ordered by most recent decision date.
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
FDA 510(k)
FDA Class 2
·Anesthesiology
eRapid with eTrack System
FDA 510(k)
FDA Class 2
·Anesthesiology
Mesh Nebulizer (H6)
FDA 510(k)
FDA Class 2
·Anesthesiology
Portable mesh nebulizer (JM821)
FDA 510(k)
FDA Class 2
·Anesthesiology
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
FDA 510(k)
FDA Class 2
·Anesthesiology
HeroTracker Sense
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Instrumentation Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | May 1, 2019 | Substantially Equivalent |
| K162753 | RTC 26-C Inline Aerosol Adapter | Feb 28, 2017 | Substantially Equivalent |
| K113644 | PILOT TUBE REPAIR KIT | Jan 26, 2012 | Substantially Equivalent |
| K102127 | ENDOTRACHEAL TUBE CHANGERS | Aug 27, 2010 | Substantially Equivalent |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | Jul 22, 2010 | Substantially Equivalent |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Sep 12, 2008 | Substantially Equivalent |
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Sep 11, 2008 | Substantially Equivalent |
| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | Jan 27, 2000 | Substantially Equivalent |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | Sep 17, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR | Aug 17, 1999 | Substantially Equivalent |