Kpe 220 TS, Nonsterile
FDA 510(k) K914221 · Ipax, Inc.
510(k) numberK914221
Submission
- Device name
- Kpe 220 TS, Nonsterile
- Applicant
- Ipax, Inc.
Englewood, CO, US - Received
- August 23, 1991
- Decision date
- October 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code HQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | Visioncare Devices, LLC | 08/10/2022SE |
| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | Medical Instrument Development Laboratories | 04/29/2016SE |
| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
| K121675 | VersavitHQE · Traditional | Synergetics, Inc. | 06/21/2012SE |
| K120170 | Procare Plus Vitrectomy SystemHQE · Traditional | Visioncare Devices, Inc. | 05/30/2012SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/08/2011SE |
| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200893 | ProntoPump Sterile Tube SetLHI · Traditional | 05/04/2021SE |
| K971242 | Blink Gold Evelid Weight (BG 06 Thru BG 28)MML · Traditional | 12/17/1997SE |
| K971245 | Blink External Eyelid WeightMML · Traditional | 06/20/1997SE |
| K915158 | Surebreath Dome, E-Z BreatherGAD · Traditional | 02/12/1992SE |
| K915118 | Phaco Emulsification,Irrigation/Aspiration TubeHQC · Traditional | 12/27/1991SE |
| K914172 | Kpe 230 AmHQC · Traditional | 10/25/1991SE |
| K884076 | Surebreath DomeGAD · Traditional | 10/07/1988SE |
| K873097 | Procedual Changes/Assembly Process for Plus PaksGBQ · Traditional | 09/04/1987SE |
| K870770 | Timleine(Tm) Venipuncture SystemKMK · Traditional | 04/23/1987SE |
| K864726 | I/A/Kpe TipHQC · Traditional | 01/20/1987SE |
Questions and answers
When was Kpe 220 TS, Nonsterile cleared by the FDA?
Kpe 220 TS, Nonsterile (K914221) received a 510(k) decision of Substantially Equivalent on October 25, 1991, 63 days after the submission was received.
What is the product code of K914221?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.