2 FR Kelman Chamber Maintainer
FDA 510(k) K792096 · Heyer Schulte Corp.
510(k) numberK792096
Submission
- Device name
- 2 FR Kelman Chamber Maintainer
- Applicant
- Heyer Schulte Corp.
Mchenry, IL, US - Received
- October 18, 1979
- Decision date
- November 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K790842 | Subcutaneous Tissue ExpanderLCJ · Traditional | 08/03/1979SE |
| K780706 | Lumbar Nerve Root Shield · Traditional | 09/07/1978SE |
| K780417 | Aseptic Transfer SetGAZ · Traditional | 04/18/1978SE |
| K771224 | Radovan Subcutaneous Tissue ExpanderLCJ · Traditional | 10/11/1977SE |
| K760778 | T-Tube Drain, RoundGCY · Traditional | 11/03/1976SE |
| K760785 | Mishler 2 Chamb Flushing Valve,Anti-SyphJXG · Traditional | 11/01/1976SE |
| K760784 | Mishler 2 Chamb Flushing Valve,StandJXG · Traditional | 11/01/1976SE |
| K760501 | Valve, Standard Model Pudenze FlushingJXG · Traditional | 08/30/1976SE |
Questions and answers
When was 2 FR Kelman Chamber Maintainer cleared by the FDA?
2 FR Kelman Chamber Maintainer (K792096) received a 510(k) decision of Substantially Equivalent on November 16, 1979, 29 days after the submission was received.
What is the product code of K792096?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.