Bodyguard
FDA 510(k) K000441 · Vital Signs, Inc.
510(k) numberK000441
Submission
- Device name
- Bodyguard
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- February 10, 2000
- Decision date
- April 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
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| K112902 | Enflow IV Fluid WarmerLGZ · Traditional | 03/14/2012SE |
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| K030985 | Breas PV 10I CPAP System, Model PV 10IBZD · Traditional | 10/15/2003SE |
| K022402 | Disposable Pressure ManometerCAP · Traditional | 08/22/2002SE |
| K021315 | Sure-LokFMI · Abbreviated | 08/21/2002SE |
| K002454 | Breas HA50 Humidifier, Model HA50BTT · Abbreviated | 03/07/2001SE |
| K001553 | Breas PV 100 CPAP SystemBZD · Traditional | 08/03/2000SE |
| K994044 | Cleen-AbleDXQ · Traditional | 02/25/2000SE |
| K990412 | Cuff-Able PlusDXQ · Traditional | 09/01/1999SE |
| K984468 | Vital PepBWF · Traditional | 06/01/1999SE |
Questions and answers
When was Bodyguard cleared by the FDA?
Bodyguard (K000441) received a 510(k) decision of Substantially Equivalent on April 11, 2000, 61 days after the submission was received.
What is the product code of K000441?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.