Pharma-Plast Insulin Infusion Set
FDA 510(k) K884978 · Pharma-Plast USA, Inc.
510(k) numberK884978
Submission
- Device name
- Pharma-Plast Insulin Infusion Set
- Applicant
- Pharma-Plast USA, Inc.
Canada H3a 2n4, CA - Received
- November 30, 1988
- Decision date
- June 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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|---|---|---|---|
| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/13/2021SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K894371 | Nipro Safelet CathFOZ · Traditional | 10/25/1989SE |
| K894373 | Nipro Dental NeedleDZM · Traditional | 10/13/1989SE |
| K894374 | Blood Drawing NeedleFMI · Traditional | 09/28/1989SE |
| K894372 | Nipro Needle HolderFMI · Traditional | 09/28/1989SE |
| K871263 | Multiple Pharma-Plast Tracheal TubeBTR · Traditional | 06/15/1987SE |
| K852444 | Asik 'Once' SyringeFMF · Traditional | 10/16/1985SE |
| K852443 | Pharma-Plast ClinipakFMF · Traditional | 10/16/1985SE |
| K852442 | Pharma-Plast NeedleFMI · Traditional | 09/20/1985SE |
Questions and answers
When was Pharma-Plast Insulin Infusion Set cleared by the FDA?
Pharma-Plast Insulin Infusion Set (K884978) received a 510(k) decision of Substantially Equivalent on June 21, 1989, 203 days after the submission was received.
What is the product code of K884978?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.