Paragon 8500 Cardio-Pulmonary Bed

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K872924 ↗

FDA Product Code

FNL

Device Class

Class II

Regulation

21 CFR Part 880.5100

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Surgimed - Surgical Blades

  Class I

  FDA 510(k) K851157 Active Cleared 25 Apr 1985

• Balloon Catheter

  Not classified

  FDA 510(k) K810689 Active Cleared 28 Jul 1981

• Silvertorque Visceral Catheter

  Class II

  FDA 510(k) K840761 Active Cleared 11 Jun 1984

• Megabed 1000

  Class II

  FDA 510(k) K872925 Active Cleared 15 Sep 1987

• Keane Mobility Bed

  Class II

  FDA 510(k) K873047 Active Cleared 15 Oct 1987

• Silvertorque Cardiac Catheters

  Class II

  FDA 510(k) K840763 Active Cleared 13 Jun 1984

See all devices from Surgimed, Inc. →

• What types of patients is the Paragon 8500 Cardio-Pulmonary Bed specifically designed to support in a clinical setting?

  The Paragon 8500 Cardio-Pulmonary Bed is designed to support patients requiring cardio-pulmonary monitoring and care, particularly those with respiratory or circulatory needs. Its features help ensure stability and accessibility during clinical procedures, making it suitable for general hospital settings where such patients are treated.

• Is the Paragon 8500 Cardio-Pulmonary Bed intended for single-use or can it be reused in a hospital environment?

  The Paragon 8500 is supplied as a reusable device, meaning it is built for repeated use in clinical settings after proper cleaning and maintenance. There is no mention of sterility requirements in the provided data, so adherence to standard hospital infection control protocols would be necessary for reuse.

• How was the FDA clearance for this bed determined, and what does the product code FNL indicate about its intended use?

  The Paragon 8500 received FDA 510(k) clearance under the product code FNL, which classifies it as a general hospital bed under the traditional review pathway. The decision was based on substantial equivalence to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously cleared product. The product code FNL does not specify a clinical indication but rather categorizes it as a standard hospital bed.

• When was the Paragon 8500 Cardio-Pulmonary Bed originally submitted to the FDA, and what was the outcome of that submission?

  The Paragon 8500 was originally submitted to the FDA on July 27, 1987, under the 510(k) pathway (K872924). The submission was reviewed by the Hospital Devices (HO) Advisory Committee, and the device was cleared as substantially equivalent (SESE) on October 9, 1987, allowing it to enter the market with the same intended use as its predicate.