CHEMOLOCK, CHEMOLOCK PORT— 510(k) K131549
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K131549 for CHEMOLOCK, CHEMOLOCK PORT, Substantially Equivalent on 2013-07-26. Applicant: Icu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
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More clearances from Icu Medical, Inc.
view allAdverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131549
K-number listed on FDA's recall record- Z-2210-2026 — Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
- Z-0328-2026 — ChemoLock Bag Spike, 01 units REF: CL-10-10
- Z-0329-2026 — ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
- Z-0330-2026 — ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
- Z-0331-2026 — ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
- Z-0332-2026 — ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
- Z-0333-2026 — ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
- Z-0334-2026 — ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
- Z-0335-2026 — ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
- Z-0336-2026 — ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
- Z-0337-2026 — ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
- Z-0338-2026 — ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
- Z-0339-2026 — ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
- Z-0340-2026 — ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
- Z-0341-2026 — ICU Medical ChemoLock Bag Spike REF: CL-10
- Z-0342-2026 — ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
- Z-0343-2026 — ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
- Z-0344-2026 — ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
- Z-0345-2026 — ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
- Z-0346-2026 — ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131549.
Data sourced from openFDA. This site is unofficial and independent of the FDA.