IV Start Kit
FDA 510(k) K941469 · Clinical Resources, Inc.
510(k) numberK941469
Submission
- Device name
- IV Start Kit
- Applicant
- Clinical Resources, Inc.
Elgin, IL, US - Received
- March 28, 1994
- Decision date
- May 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRS – I.V. Start Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification…
Other 510(k)s with product code LRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050654 | Amsino I.V. Start KitLRS · Traditional | Amsino International, Inc. | 05/02/2005SE |
| K001879 | Infusion IV SetLRS · Traditional | Nirvi Intl. USA | 11/20/2001SE |
| K963722 | IV Start KitLRS · Traditional | Grand Medical Products | 11/27/1996SE |
| K951167 | EMS I.V. Start KitLRS · Traditional | Emergency Medical Supply, Inc. | 05/16/1995SN |
| K950184 | B. Braun IV Start KitsLRS · Traditional | B. Braun of America, Inc. | 03/15/1995SEKD |
| K944041 | Personal Hearing SystemLRS · Traditional | Resound Corp. | 12/27/1994SE |
| K943941 | Safestart Vascular Access Start KitLRS · Traditional | Becton Dickinson Vascular Access, Inc. | 10/20/1994SE |
| K935684 | IV Start KitLRS · Traditional | Cush Medical Products | 06/10/1994SEKD |
| K942238 | I.V. Startpak Vascular Access Start KitLRS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/03/1994SE |
| K925018 | IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional | Customed, Inc. | 08/27/1993SEKD |
More from Customed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941470 | Tracheostomy Care KitBTO · Traditional | 02/14/1995SESK |
| K944882 | Irrigation TrayEYN · Traditional | 01/12/1995SE |
| K944881 | Skin Scrub TrayFRG · Traditional | 12/27/1994SEKD |
| K945021 | Fluff Gauze SpongeEFQ · Traditional | 12/23/1994SE |
| K945020 | Fluff Gauze SpongeEFQ · Traditional | 12/23/1994SE |
| K945019 | Fluff Gauxze RollEFQ · Traditional | 12/23/1994SE |
| K944879 | Gauze SpongesGDY · Traditional | 12/23/1994SE |
| K944880 | Bodily Fluid Disposal KitFXX · Traditional | 12/15/1994SE |
| K941471 | Central Line Dressing Change TrayFRG · Traditional | 05/12/1994SE |
| K941468 | Debridement Tray, Incision and Drainage TrayFRG · Traditional | 05/12/1994SE |
Questions and answers
When was IV Start Kit cleared by the FDA?
IV Start Kit (K941469) received a 510(k) decision of Substantially Equivalent on May 12, 1994, 45 days after the submission was received.
What is the product code of K941469?
The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.