Product code LRS— 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 (510(k)) to market if it meets all criteria in the guidance.”

FDA has cleared 30 devices under product code LRS between 1976 and 2005, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20051 clearance
• 20011 clearance
• 19961 clearance
• 19952 clearances
• 19945 clearances
• 19939 clearances
• 19921 clearance
• 19881 clearance
• 19872 clearances
• 19862 clearances
• 19851 clearance
• 19842 clearances
• 19821 clearance
• 19761 clearance

• Customed, Inc.2 clearances
• Trinity Laboratories, Inc.1 clearance
• Transidyne General Corp.1 clearance
• The Kendal Co.1 clearance
• The Jarid Group, Inc.1 clearance
• Telstar Electronics, Inc.1 clearance
• Specialty Medical Products Co.1 clearance
• Sherwood Medical Industries1 clearance
• Seamless Hospital Products Co.1 clearance
• Resound Corp.1 clearance

Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K050654 — AMSINO I.V. START KITAmsino International, Inc.·2005-05-02
• K001879 — INFUSION IV SETNirvi Intl. USA·2001-11-20
• K963722 — IV START KITGrand Medical Products·1996-11-27
• K951167 — EMS I.V. START KITEmergency Medical Supply, Inc.·1995-05-16
• K950184 — B. BRAUN IV START KITSB. Braun of America, Inc.·1995-03-15
• K944041 — PERSONAL HEARING SYSTEMResound Corp.·1994-12-27
• K943941 — SAFESTART VASCULAR ACCESS START KITBecton Dickinson Vascular Access, Inc.·1994-10-20
• K935684 — IV START KITCush Medical Products·1994-06-10
• K942238 — I.V. STARTPAK VASCULAR ACCESS START KITBd Becton Dickinson Vacutainer Systems Preanalytic·1994-06-03
• K941469 — IV START KITClinical Resources, Inc.·1994-05-12
• K925017 — IV PREP KIT (NON-STERILE)Customed, Inc.·1993-08-27
• K925018 — IV PREP KIT W/O DRESSING (NON-STERILE)Customed, Inc.·1993-08-27
• K933041 — COLD CD ASP MODULE, ITEElectone, Inc.·1993-08-02
• K924538 — IV START KITCml, Inc.·1993-07-02
• K930196 — CEPTI-SEAL I.V. PREP KITMedi-Flex Hospital Products, Inc.·1993-07-02
• K923361 — I.V. START KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.·1993-06-28
• K924811 — I.V. START KITTransidyne General Corp.·1993-06-17
• K926031 — PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KITBrigam Medical, Inc.·1993-06-07
• K922533 — IV START KIT CUSTOM SMP # A-ZSpecialty Medical Products Co.·1993-03-23
• K914475 — IV START KITCypress Medical Products, Ltd.·1992-03-18
• K875315 — I.V. START KITSNi-Med, Inc.·1988-02-17
• K871731 — TELSTAR PREWIRE SERIESTelstar Electronics, Inc.·1987-10-27
• K871281 — IV START KITThe Jarid Group, Inc.·1987-05-27
• K863796 — CREATIVE CARE SYSTEMS' IV START KITAmerican Biomaterials Corp.·1986-11-28
• K863712 — I.V. START KIT, STERILE, DISPOSABLESBusse Hospital Disposables, Inc.·1986-10-22
• K852375 — I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVEFerris Mfg. Corp.·1985-07-11
• K844614 — IV START KITPackaging Technologies, Inc.·1984-12-19
• K842898 — CURITY I.V. START KITThe Kendal Co.·1984-08-17
• K820490 — IV START TRAYSeamless Hospital Products Co.·1982-03-16
• K760876 — ARGYLE IV STARTER KIT (W/O DRUG)Sherwood Medical Industries·1976-12-09