FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDELA SUCTION PUMP
K Number: K830012
·
Decision Jan 24, 1983
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
29
Applicant Total
19
Review Days
21
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Basic Information
- Device Name
- MEDELA SUCTION PUMP
- K Number
- K830012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Medela, Inc.
- Date Received
- January 3, 1983
- Decision Date
- January 24, 1983
- Product Code
- HDB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDB), ordered by most recent decision date.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
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MEDELA SINGLE USE SILC CUP, MODEL 077.0791
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VACULINK, MODEL VCL 3000
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FDA Class 2
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FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
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FDA Class 2
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MITYVAC MERLIN, MODEL 10027
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SWIFT LOW PROFILE CUP (PRO CUP)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Medela, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161811 | Medela Low Dose Enteral Syringe | Feb 15, 2017 | Substantially Equivalent |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | Oct 28, 2016 | Substantially Equivalent |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | Jun 6, 2003 | Substantially Equivalent |
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | Mar 7, 2002 | Substantially Equivalent |
| K984589 | PHOTOTHERAPY LAMP | Apr 20, 1999 | Substantially Equivalent |
| K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO | Jan 7, 1999 | Substantially Equivalent |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Dec 12, 1996 | Substantially Equivalent |
| K950750 | MEDELAS BREAST PUMP | Oct 16, 1995 | Substantially Equivalent |
| K952034 | MEDELA'S FOOT PUMP | Sep 12, 1995 | Substantially Equivalent |
| K923577 | BREAST SHELLS | Jan 22, 1993 | Substantially Equivalent |