Omnimed Superior Transducer Protector
FDA 510(k) K851734 · Omni Intl., Inc.
510(k) numberK851734
Submission
- Device name
- Omnimed Superior Transducer Protector
- Applicant
- Omni Intl., Inc.
Palm Springs, CA, US - Received
- April 25, 1985
- Decision date
- May 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIB – Protector, Transducer, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/28/2024SE |
| K072988 | Nipro Transducer Protector Tp-Sure, Model TPSURE+1FIB · Traditional | Nipro Medical Corporation | 02/21/2008SE |
| K001971 | Hemodialysis Tubing SetsFIB · Traditional | Ofi Biomedica S.P.A. | 05/24/2001SE |
| K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 04/27/2001SE |
| K001465 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 12/05/2000SE |
| K003445 | Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2FIB · Special | Fresenius Medical Care North America | 12/01/2000SE |
| K000702 | Borla Transducer Protector & Haemotronic Transducer ProtectorFIB · Traditional | Fresenius Medical Care North America | 06/07/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | Medisystems Corp. | 11/25/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | Circulatory Technology, Inc. | 05/23/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | Medisystems Corp. | 05/12/1997SE |
More from Medisystems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984066 | Omnigrip, Latex Surgical Glove, Powder-Free with Protein Labeling ClaimKGO · Traditional | 01/13/1999SE |
| K984064 | Omnigrip, Latex Surgical Glove, Powder FreeKGO · Traditional | 01/08/1999SE |
| K853255 | Omnimed I.V. Solution Admin. SetFPA · Traditional | 08/23/1985SE |
| K851938 | Omnimed Surgical GownFYA · Traditional | 06/28/1985SE |
| K851654 | Omnimed ClampHXD · Traditional | 05/31/1985SE |
| K850706 | F-Series ImplantDZE · Traditional | 04/10/1985SE |
| K850112 | Omnimed IV Solution Administration SetFPA · Traditional | 02/22/1985SE |
| K850066 | Omnimed Nasal Oxygen CannulaCAT · Traditional | 01/24/1985SE |
| K831147 | Omniprobe Electrical Nerve StimulatorGZJ · Traditional | 07/18/1983SE |
| K821523 | Omni TENSGZJ · Traditional | 06/16/1982SE |
Questions and answers
When was Omnimed Superior Transducer Protector cleared by the FDA?
Omnimed Superior Transducer Protector (K851734) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 28 days after the submission was received.
What is the product code of K851734?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.