FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProntoPump Sterile Tube Set
K Number: K200893
·
Decision May 4, 2021
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
18
Review Days
396
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Basic Information
- Device Name
- ProntoPump Sterile Tube Set
- K Number
- K200893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ipax, Inc.
- Date Received
- April 3, 2020
- Decision Date
- May 4, 2021
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Ipax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971242 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | Dec 17, 1997 | Substantially Equivalent |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Jun 20, 1997 | Substantially Equivalent |
| K915158 | SUREBREATH DOME, E-Z BREATHER | Feb 12, 1992 | Substantially Equivalent |
| K915118 | PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE | Dec 27, 1991 | Substantially Equivalent |
| K914172 | KPE 230 AM | Oct 25, 1991 | Substantially Equivalent |
| K914221 | KPE 220 TS, NONSTERILE | Oct 25, 1991 | Substantially Equivalent |
| K884076 | SUREBREATH DOME | Oct 7, 1988 | Substantially Equivalent |
| K873097 | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS | Sep 4, 1987 | Substantially Equivalent |
| K870770 | TIMLEINE(TM) VENIPUNCTURE SYSTEM | Apr 23, 1987 | Substantially Equivalent |
| K864726 | I/A/KPE TIP | Jan 20, 1987 | Substantially Equivalent |