MSI 2002 Series Bed

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

510(k) Number

K881027 ↗

FDA Product Code

FNL

Device Class

Class II

Regulation

21 CFR Part 880.5100

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Msi 3003 Series Bed

  Class I

  FDA 510(k) K881964 Active Cleared 28 Jun 1988

• Msi 3002 Series Bed

  Class II

  FDA 510(k) K881963 Active Cleared 28 Jun 1988

• Msi 9000 Series Bed

  Class II

  FDA 510(k) K873291 Active Cleared 30 Dec 1987

• Msi Standard Bed Models: L1097-64 and L1085-64

  Class I

  FDA 510(k) K881961 Active Cleared 1 Nov 1988

• Msi 4000 Series Bed

  Class II

  FDA 510(k) K881782 Active Cleared 12 Jul 1988

• Msi 2005 Series Bed

  Class I

  FDA 510(k) K881962 Active Cleared 3 Jun 1988

See all devices from Med Service, Inc. →

• Is the MSI 2002 Series Bed safe to use in an MRI environment, and how does that affect its reuse policy?

  Yes, the MSI 2002 Series Bed is explicitly labeled as MRI safe, meaning it can be used in magnetic resonance imaging environments without interference or risk to patients. Since it is designed as a reusable device, its MRI-safe status applies to each use cycle, provided it is maintained according to manufacturer guidelines and undergoes proper cleaning and inspection between patients.

• What types of healthcare settings is this bed intended for, and does it have any specific limitations based on its design?

  The MSI 2002 Series Bed is designed specifically for patient care in hospital settings, as indicated by its classification under the FDA’s General Hospital advisory committee (HO). While it is not restricted to a single type of hospital unit, its primary purpose is to provide adjustable support for patients in acute care environments. There are no limitations mentioned in the data regarding patient weight, bed height, or specialized care needs, but its use should align with standard hospital bed protocols.

• How is the MSI 2002 Series Bed supplied, and what does that mean for its maintenance and longevity?

  The MSI 2002 Series Bed is supplied as a reusable device, meaning it is built for repeated use across multiple patients with proper cleaning, disinfection, and maintenance. This design implies it is intended for long-term service in a hospital, requiring adherence to institutional protocols for sterilization (if applicable) and routine inspections to ensure safety and functionality. Unlike single-use devices, its durability is a key factor in cost-effectiveness for healthcare facilities.

• What does the FDA’s 510(k) clearance with product code FNL indicate about the bed’s regulatory pathway and intended use?

  The FDA’s 510(k) clearance with product code FNL (Furniture, Non-Powered) confirms that the MSI 2002 Series Bed has been determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. This classification does not define clinical indications but rather confirms the device’s compliance with regulatory expectations for hospital beds in the General Hospital category (HO advisory committee). It does not imply any specific patient population or medical condition.