Atlas FDA

CHEMOLOCK, CHEMOLOCK PORT

FDA 510(k) clearance K131549 · decided 2013-07-26

Clearance details

K-number
K131549
Device name
CHEMOLOCK, CHEMOLOCK PORT
Applicant
Icu Medical, Inc.
Decision
Substantially Equivalent
Date received
2013-05-29
Decision date
2013-07-26
Days to decision
58 days
Clearance type
Traditional
Product code
ONB
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-S recall (Z-2210-2026)ICU Medical, Inc.2026-05-18
ChemoLock Bag Spike, 01 units REF: CL-10-10 recall (Z-0328-2026)ICU Medical, Inc.2025-10-27
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 recall (Z-0329-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS recall (Z-0330-2026)ICU Medical, Inc.2025-10-27
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 recall (Z-0331-2026)ICU Medical, Inc.2025-10-27
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall (Z-0332-2026)ICU Medical, Inc.2025-10-27
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Ch recall (Z-0333-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip recall (Z-0334-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 recall (Z-0335-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 recall (Z-0336-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; Chemo recall (Z-0337-2026)ICU Medical, Inc.2025-10-27
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Va recall (Z-0338-2026)ICU Medical, Inc.2025-10-27
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w recall (Z-0339-2026)ICU Medical, Inc.2025-10-27
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLoc recall (Z-0340-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Bag Spike REF: CL-10 recall (Z-0341-2026)ICU Medical, Inc.2025-10-27
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 recall (Z-0342-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 recall (Z-0343-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S recall (Z-0344-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 recall (Z-0345-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 recall (Z-0346-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S recall (Z-0347-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 recall (Z-0348-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 recall (Z-0349-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Port REF: CL2100 recall (Z-0350-2026)ICU Medical, Inc.2025-10-27
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 recall (Z-0351-2026)ICU Medical, Inc.2025-10-27
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 recall (Z-0352-2026)ICU Medical, Inc.2025-10-27
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 recall (Z-0353-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20 recall (Z-0354-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock w/Mini Bag Spike REF: C-17 recall (Z-0355-2026)ICU Medical, Inc.2025-10-27
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 recall (Z-0356-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 recall (Z-0357-2026)ICU Medical, Inc.2025-10-27
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating L recall (Z-0358-2026)ICU Medical, Inc.2025-10-27
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall (Z-0359-2026)ICU Medical, Inc.2025-10-27
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter recall (Z-0360-2026)ICU Medical, Inc.2025-10-27
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating recall (Z-0361-2026)ICU Medical, Inc.2025-10-27
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLo recall (Z-0362-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 recall (Z-0363-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 recall (Z-0364-2026)ICU Medical, Inc.2025-10-27
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 K recall (Z-0365-2026)ICU Medical, Inc.2025-10-27
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents recall (Z-0652-2025)ICU Medical, Inc.2024-12-09
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV admini recall (Z-1096-2019)ICU Medical, Inc.2019-04-15
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfe recall (Z-0805-2019)ICU Medical, Inc.2019-02-22