LRS — I.V. Start Kit Class II
FDA product code LRS covers "I.V. Start Kit", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LRS
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General Hospital
- Implant
- No
Definition
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 (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050654 | amsino international | AMSINO I.V. START KIT | May 2, 2005 |
| K001879 | nirvi intl. usa | INFUSION IV SET | November 20, 2001 |
| K963722 | grand medical products | IV START KIT | November 27, 1996 |
| K951167 | emergency medical supply | EMS I.V. START KIT | May 16, 1995 |
| K950184 | b. braun of america | B. BRAUN IV START KITS | March 15, 1995 |
| K944041 | resound | PERSONAL HEARING SYSTEM | December 27, 1994 |
| K943941 | becton dickinson vascular access | SAFESTART VASCULAR ACCESS START KIT | October 20, 1994 |
| K935684 | cush medical products | IV START KIT | June 10, 1994 |
| K942238 | bd becton dickinson vacutainer systems preanalytic | I.V. STARTPAK VASCULAR ACCESS START KIT | June 3, 1994 |
| K941469 | clinical resources | IV START KIT | May 12, 1994 |
| K925018 | customed | IV PREP KIT W/O DRESSING (NON-STERILE) | August 27, 1993 |
| K925017 | customed | IV PREP KIT (NON-STERILE) | August 27, 1993 |
| K933041 | electone | COLD CD ASP MODULE, ITE | August 2, 1993 |
| K930196 | medi-flex hospital products | CEPTI-SEAL I.V. PREP KIT | July 2, 1993 |
| K924538 | cml | IV START KIT | July 2, 1993 |
| K923361 | trinity laboratories | I.V. START KIT, STERILE, DISPOSABLE | June 28, 1993 |
| K924811 | transidyne general | I.V. START KIT | June 17, 1993 |
| K926031 | brigam medical | PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT | June 7, 1993 |
| K922533 | specialty medical products | IV START KIT CUSTOM SMP # A-Z | March 23, 1993 |
| K914475 | cypress medical products | IV START KIT | March 18, 1992 |