Product code DRY— Cardiovascular
CDI BLOOD PARAMETER MONITORING SYSTEM 500
- Classification name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code DRY
FDA has cleared devices under product code DRY between 1981 and 2024, filed by 33 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2021
- 2020
- 2018
- 2017
- 2014
- 2012
- 2011
- 2009
- 2007
- 2006
- 2001
- 2000
- 1998
- 1997
Top applicants under product code DRY
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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 →
Recent clearances under product code DRY
- K234065 — CDI OneView Monitoring System
- K202154 — B-Capta
- K202557 — Quantum Workstation 12 Elite
- K182110 — CDI Blood Parameter Monitoring System 550
- K181923 — Quantum Workstation 12.1
- K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
- K163657 — Quantum Workstation
- K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
- K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K110957 — M4 MONITOR
- K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
- K091908 — M3 MONITOR
- K090147 — BLOOD MONITORING UNIT, MODEL BMU 40
- K072131 — M3 MONITOR
- K071725 — M2 MONITOR
- K062468 — SPECTRUM M2 MONITOR
- K012743 — TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
- K001388 — DATA MASTER PERFUSION MONITORING SYSTEM
- K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
- K973472 — 3M CDI H/S CUVETTES WITH HEPARON TREATMENT
- K972962 — 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
- K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
- K941922 — MEDSAT OXYGEN SATURATION SYSTEM
- K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
- K915255 — CDI(TM) 300, 400 & 100, MODIFICATION
- K915265 — CDI(TM) H/S CUVETTE, MODIFICATION
- K910421 — SATURATION/HEMATOCRIT MONITOR SYSTEM
- K903729 — GOLD GATORS
- K900459 — APPLICARD (EKG)
- K900682 — PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
- K881006 — STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
- K874839 — STAT-SAT
- K871686 — GEM-CRIT CHECK
- K871221 — CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
- K862953 — CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
- K862069 — CARDIOMET 4000 GAS MONITORING SYSTEMS
- K861277 — CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
- K854357 — GEM-6, WITH COMPONENTS
- K852124 — HEMATOCRIT-SATURATION MONITOR HSM-100
- K843709 — COBE SATURATION CELL
- K843538 — PO 2 LYTRODE
- K831225 — GAS-STAT MONITORING SYSTEM
- K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100
- K821159 — IN-LINE OXYGEN MONITORING SYSTEM
- K811391 — OXIMETRIX ACCU SAT CPB
Data sourced from openFDA. This site is unofficial and independent of the FDA.