Sp-30010
Sp-30010 is an instrument/equipment drape (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Summit Medical, LLC, cleared under FDA 510(k) K911785 on 7 Oct 1991 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 00385640000079), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385640000079 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK911785 | Date7 Oct 1991 | StatusActive |
Official records
- AccessGUDID record 00385640000079
- FDA 510(k) database K911785
Across registries
- FDA 510(k) K911785 decided 7 Oct 1991 Active
- FDA GUDID UDI-DI 00385640000079 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K911785
- Listed FDA GUDID 00385640000079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Instrument/equipment drape, single-use, non-sterile
- Model / reference
- SP-30010
- Primary DI / UDI-DI
- 00385640000079
- 510(k) Number
- FDA product code
- CAF
- GMDN term
- Instrument/equipment drape, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
- METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D by Instrumentation Industries, Inc.
- AG-PLUS, MODEL 91210 by Medel S.P.A.
- LC SPRINT NEBULIZER by Pari Innovative Manufacturers, Inc.
- DOSER by Newmed Corp.
- AIRLIFE NEBULIZER HEATER by Airlife, Inc.
- VENTSTREAM DRUG NEBULIZER by Medic-Aid, Ltd.
- Portable Nebulizer by MICROBASE TECHNOLOGY CORP.
- SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 by Hudson Respiratory Care, Inc.
- Hailie Sensor NF0106 by Adherium (Nz), Ltd.
- NEBULIZER WITH 4-WAY T NO M-174 by Mem Medical, Inc.