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Waters Assoc., Inc.

United StatesFDA applicant, unverified

Devices
16

What Waters Assoc., Inc. makes

Waters Associates, Inc. manufactures medical devices including respiratory monitoring tools like the MRM-2 Oxygen Consumption Monitor, cardiac output computers (CO-10 and CO-10R), and vascular catheters such as the 7French Flow Directed Triple Lumen Catheter and 4French Sterile Balloon-Less Catheter. The company also produces laboratory and analytical instruments, such as the Fluorescence Detector Model 420, Variable Wavelength Ultraviolet Spectrophotometer (Model 480), and dynamic calibrators for medical and research use. Additional offerings include medical trays (e.g., PAB Convenience Tray) and recording devices like the RE-100P Hot Stylus Strip Chart Recorder.

The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I or Class II. These instruments are listed in the FDA’s 510(k) database, indicating their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

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  • Mrm-2 Oxygen Consumption Monitor Ref K801852

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiac Computers, Co-10 & Co-10R Ref K781805

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 7FRENCH Flow Directed Triple Lumen Cath Ref K802481

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pab Convenience Tray Ref K781264

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 4F Sterile Balloon-Less, Catheter 913-28 Ref K791026

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • System Controller 720 Series Ref K791661

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Calibrator, Dynamic Ref K781692

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fluorescence Detector Model 420 Ref K780031

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cartridge Holder, Rcm 100 Ref K782175

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Model 480 Variable Wavelength Ultra Viol Ref K811975

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Recorder, Re-100P Hot Stylus Strip Chart Ref K780245

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tc-1 Cardiac Output Computer Ref K761166

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pan-Am Myelogram Tray Ref K801431

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Solvent Delivery System Ref K790145

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Data Module Ref K781915

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Wisp Model 710 Ref K772311

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-16 of 16

Frequently asked questions

How many devices does Waters Assoc., Inc. have in the registry?

The registry currently lists 16 devices for Waters Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Waters Assoc., Inc.'s devices?

Among its 16 most recently registered devices, Waters Assoc., Inc. has devices listed in FDA 510(k) (16 devices).

What risk classes do Waters Assoc., Inc.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Waters Assoc., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Waters Assoc., Inc. in the registry?

The most recently registered devices listed for Waters Assoc., Inc. include MRM-2 OXYGEN CONSUMPTION MONITOR, CARDIAC COMPUTERS, CO-10 & CO-10R, 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH and PAB CONVENIENCE TRAY.

Generated automatically from registry data and not verified by a human reviewer.