Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1915](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1915) → KRB — Probe, Thermodilution # KRB · Probe, Thermodilution _Cardiovascular · 21 CFR 870.1915 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB ## Overview - **Product Code:** KRB - **Device Name:** Probe, Thermodilution - **Regulation:** [21 CFR 870.1915](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1915) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K171620](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K171620.md) | PiCCO Catheter | Pulsion Medical Systems SE | Feb 21, 2018 | SESE | | [K100739](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K100739.md) | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | Dec 7, 2010 | SESE | | [K072364](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K072364.md) | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | Pulsion Medical Systems AG | Sep 19, 2007 | SESE | | [K020587](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K020587.md) | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | Pulsion Medical Systems AG | May 23, 2002 | SESE | | [K991886](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K991886.md) | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | Pulsion Medical Systems, Inc. | May 11, 2000 | SESE | | [K936182](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K936182.md) | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | Ohmeda Medical | Mar 25, 1994 | SESE | | [K915627](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K915627.md) | PACEVIEW | Micromedical Industries, Ltd. | Mar 27, 1992 | SESE | | [K912172](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K912172.md) | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sunscope Intl., Inc. | Sep 27, 1991 | SESE | | [K902627](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K902627.md) | INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. | Biometric Research Institute, Inc. | Feb 25, 1991 | SESE | | [K900710](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K900710.md) | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | Intec Medical, Inc. | Oct 19, 1990 | SESE | | [K900317](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K900317.md) | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER | Elecath | Jun 22, 1990 | SESE | | [K892941](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K892941.md) | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Spectramed, Inc. | Nov 6, 1989 | SESE | | [K884318](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K884318.md) | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | Abbott Laboratories | Dec 13, 1988 | SESE | | [K881893](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K881893.md) | NUMED BALLOON THERMODILUTION CATHETER | NuMED, Inc. | Sep 6, 1988 | SESE | | [K874522](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K874522.md) | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | Jan 29, 1988 | SESE | | [K864818](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K864818.md) | ACKRAD TDI SET | Ackrad Laboratories | Apr 9, 1987 | SESE | | [K843412](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K843412.md) | FLOW DIRECTED THERMODILUTION CATH W/VEN | Andover Medical, Inc. | Nov 20, 1984 | SESE | | [K843410](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K843410.md) | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Andover Medical, Inc. | Nov 20, 1984 | SESE | | [K840992](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K840992.md) | THERMODILUTION CATHETER | Gould, Inc. | May 23, 1984 | SESE | | [K840824](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K840824.md) | HEPARIN COATED THERMODILUTION CATHETERS | Gould, Inc. | May 23, 1984 | SESE | ## Top Applicants - Gould, Inc. — 4 clearances - Instrumentation Laboratory CO — 3 clearances - American Edwards Laboratories — 2 clearances - Andover Medical, Inc. — 2 clearances - Edwards Laboratories — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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