Catheter Insertion Tray
FDA 510(k) K922179 · Medcare Custom Packaging, Inc.
510(k) numberK922179
Submission
- Device name
- Catheter Insertion Tray
- Applicant
- Medcare Custom Packaging, Inc.
E Swanzey, NH, US - Received
- May 8, 1992
- Decision date
- July 2, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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|---|---|---|---|
| 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 |
|---|---|---|
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | 01/19/1996SE |
| K954442 | Sterile Isotonic Saline & Sterile WaterJOL · Traditional | 12/21/1995SE |
| K952759 | Towel PackKKX · Traditional | 09/29/1995SE |
| K950390 | Urethral Catheterization TrayFCM · Traditional | 05/30/1995SE |
| K943661 | Sterile Physiological Saline/Sterile WaterJOL · Traditional | 04/10/1995SE |
| K951149 | Single Use Instrument TrayLRO · Traditional | 04/06/1995SESK |
| K934732 | Pelvic Exam TrayHHT · Traditional | 12/30/1994SE |
| K942000 | Burn Dressing TrayFRG · Traditional | 05/20/1994SESK |
| K936261 | Catheter Insertion TrayFMI · Traditional | 03/10/1994SESK |
| K901856 | Custom Wound Management Kits and TraysLRO · Traditional | 08/01/1990SESD |
Questions and answers
When was Catheter Insertion Tray cleared by the FDA?
Catheter Insertion Tray (K922179) received a 510(k) decision of Unknown on July 2, 1993, 420 days after the submission was received.
What is the product code of K922179?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.