LRS
30 FDA 510(k) clearances · Product code
72 daysmedian time to decision
337 days90th percentile
30clearances measured
FDA profile
- Official device name
- I.V. Start Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Medical specialty
- General Hospital
- FDA 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.
- Adverse events (MAUDE)
- 2012: 8 · 2013: 12 · 2023: 34 · 2024: 20 · 2025: 34 · 2026: 132
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMSINO I.V. START KIT (K050654) | Amsino International, Inc. | 2005-05-02 |
| INFUSION IV SET (K001879) | Nirvi Intl. USA | 2001-11-20 |
| IV START KIT (K963722) | Grand Medical Products | 1996-11-27 |
| EMS I.V. START KIT (K951167) | Emergency Medical Supply, Inc. | 1995-05-16 |
| B. BRAUN IV START KITS (K950184) | B. Braun of America, Inc. | 1995-03-15 |
| PERSONAL HEARING SYSTEM (K944041) | Resound Corp. | 1994-12-27 |
| SAFESTART VASCULAR ACCESS START KIT (K943941) | Becton Dickinson Vascular Access, Inc. | 1994-10-20 |
| IV START KIT (K935684) | Cush Medical Products | 1994-06-10 |
| I.V. STARTPAK VASCULAR ACCESS START KIT (K942238) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-06-03 |
| IV START KIT (K941469) | Clinical Resources, Inc. | 1994-05-12 |
| IV PREP KIT (NON-STERILE) (K925017) | Customed, Inc. | 1993-08-27 |
| IV PREP KIT W/O DRESSING (NON-STERILE) (K925018) | Customed, Inc. | 1993-08-27 |
| COLD CD ASP MODULE, ITE (K933041) | Electone, Inc. | 1993-08-02 |
| CEPTI-SEAL I.V. PREP KIT (K930196) | Medi-Flex Hospital Products, Inc. | 1993-07-02 |
| IV START KIT (K924538) | Cml, Inc. | 1993-07-02 |
| I.V. START KIT, STERILE, DISPOSABLE (K923361) | Trinity Laboratories, Inc. | 1993-06-28 |
| I.V. START KIT (K924811) | Transidyne General Corp. | 1993-06-17 |
| PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT (K926031) | Brigam Medical, Inc. | 1993-06-07 |
| IV START KIT CUSTOM SMP # A-Z (K922533) | Specialty Medical Products Co. | 1993-03-23 |
| IV START KIT (K914475) | Cypress Medical Products, Ltd. | 1992-03-18 |
| I.V. START KITS (K875315) | Ni-Med, Inc. | 1988-02-17 |
| TELSTAR PREWIRE SERIES (K871731) | Telstar Electronics, Inc. | 1987-10-27 |
| IV START KIT (K871281) | The Jarid Group, Inc. | 1987-05-27 |
| CREATIVE CARE SYSTEMS' IV START KIT (K863796) | American Biomaterials Corp. | 1986-11-28 |
| I.V. START KIT, STERILE, DISPOSABLES (K863712) | Busse Hospital Disposables, Inc. | 1986-10-22 |
| I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE (K852375) | Ferris Mfg. Corp. | 1985-07-11 |
| IV START KIT (K844614) | Packaging Technologies, Inc. | 1984-12-19 |
| CURITY I.V. START KIT (K842898) | The Kendal Co. | 1984-08-17 |
| IV START TRAY (K820490) | Seamless Hospital Products Co. | 1982-03-16 |
| ARGYLE IV STARTER KIT (W/O DRUG) (K760876) | Sherwood Medical Industries | 1976-12-09 |
Track LRS automatically
Every clearance here is in the API, with alerts when new ones post.