510(k) K100576 ยท FPA Set, Administration, Intravascular
HIGH PRESSURE SETS-400 PSI
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 17, 2010 |
| Received | Mar 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FPA | None listed |
| Aug 1, 2022 | ICU Medical, Inc. 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer; Open, Classified |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per ca Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01) Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709071 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887 Terminated |
FPA | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.