FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BASIC AND DOMINANT FLEX SUCTION PUMPS
K Number: K130123
·
Decision Oct 11, 2013
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
151
Applicant Total
19
Review Days
267
Basic Information
- Device Name
- BASIC AND DOMINANT FLEX SUCTION PUMPS
- K Number
- K130123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDELA AG
- Date Received
- January 17, 2013
- Decision Date
- October 11, 2013
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTA), ordered by most recent decision date.
Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AIRO Suction Unit (AIRO-01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Nasal Aspirator (BC026, BC025, BC023)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Geon (S2) Nasal Aspirator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by MEDELA AG
| K Number | Device Name | ||
|---|---|---|---|
| K153663 | Vario 8/18/ci | May 18, 2016 | Substantially Equivalent |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | Nov 5, 2015 | Substantially Equivalent |
| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | Apr 21, 2015 | Substantially Equivalent |
| K150134 | Basic, Dominant Flex, KV-6 | Apr 21, 2015 | Substantially Equivalent |
| K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Dec 19, 2014 | Substantially Equivalent |
| K141553 | MEDELA THOPAZ+ | Aug 25, 2014 | Substantially Equivalent |
| K130210 | MEDELA THOPAZ | Mar 15, 2013 | Substantially Equivalent |
| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Oct 1, 2012 | Substantially Equivalent |
| K080357 | MEDELA INVIA WOUND THERAPY | Jul 24, 2008 | Substantially Equivalent |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Jul 23, 2008 | Substantially Equivalent |