Adel 5000

• • Terminated Z-0793-05 FDA Unclassified (pre-2012) ·initiated 31 Mar 2005

  Trendelenburg and reverse trendelenburg features may not function.

• 3 recalls, same reason

  • Terminated Z-0524-04 FDA Unclassified (pre-2012) ·initiated 26 Jan 2004
  • Terminated Z-0525-04 FDA Unclassified (pre-2012) ·initiated 26 Jan 2004
  • Terminated Z-0526-04 FDA Unclassified (pre-2012) ·initiated 26 Jan 2004

  A potential shock hazard exists if the night light is damaged.

510(k) Number

K950889 ↗

FDA product code

HDD

Device class

Class II

Regulation

21 CFR Part 884.4900

Advisory committee

Obstetrics/Gynecology

FDA decision

SESE Substantially Equivalent

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• Is the Adel 5000 designed for single-use or can it be reused in clinical settings?

  The Adel 5000 is explicitly supplied as a reusable medical device, intended for use in regulated clinical environments like hospitals and birthing centers. Since it is not classified as disposable and has no stated sterility requirements in the data, it must be cleaned, disinfected, and maintained according to standard hospital protocols for reusable obstetrical tables.

• What types of clinical environments is the Adel 5000 intended for, and what procedures does it support?

  The Adel 5000 is designed for obstetrical and gynecological procedures, including labor, delivery, and related interventions. Its adjustable positioning and electrical functionality make it suitable for settings like hospitals and birthing centers where patient mobility and procedural support are critical during childbirth or gynecologic exams.

• How is the regulatory clearance for the Adel 5000 structured, and what does the product code HDD indicate?

  The Adel 5000 received FDA 510(k) clearance (K950889) under the Traditional Review pathway, classified as a Class II device. The product code HDD (Hospital Furniture, Obstetrical) categorizes it as an obstetrical, AC-powered table with accessories, aligning with obstetrics/gynecology specialty standards and governed by 21 CFR 884.4900.

• Are there multiple models or configurations of the Adel 5000, and how can I verify compatibility with my facility?

  The Adel 5000 appears in multiple registration numbers (e.g., 3040337865, 3015136704), which may indicate variations or configurations (e.g., different accessories or features). To confirm compatibility, check your facility’s existing infrastructure for electrical requirements and space constraints, then verify the exact model specifications with Stryker Corp. via their contact at 420 Alcott St., Kalamazoo, MI 49001.

• Does the Adel 5000 require any special storage conditions, and how should it be maintained between uses?

  While the data does not specify storage conditions, as a reusable, AC-powered obstetrical table, the Adel 5000 should be stored in a clean, dry environment protected from moisture or extreme temperatures. Between uses, it must undergo routine cleaning, disinfection, and maintenance per your facility’s infection control policies and manufacturer guidelines to ensure safety and longevity.