ClearanceBrief
510(k) K203790 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

GEM Premier 5000

ApplicantInstrumentation Laboratory CO, Bedford MA, US
DecisionSubstantially Equivalent, Aug 20, 2021
ReceivedDec 28, 2020
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K203790

DateFirm and productCodeLinked 510(k)
Aug 6, 2026Instrumentation Laboratory
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Open, Classified		 CHLNone listed
Jul 29, 2026Instrumentation Laboratory
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Read
Open, Classified		 CHLNone listed
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Open, Classified		 CHLNone listed
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Open, Classified		 CHLNone listed
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Open, Classified		 CHLNone listed
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK, Part No. 00055360004.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360008.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360010.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360011.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407504.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407508.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407510.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407511.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055415004.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415005.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415008.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No: 00055415011.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430004.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Model No. 00055430010.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430011.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445004.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008.
Open, Classified		 CHLNone listed
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Open, Classified		 CHLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.