Laerdal Suction Unit, (4000) Model 78 00 20
by Laerdal Medical A/S EUDAMED510(k)
Active
510(k) K993668
Overview
The Laerdal Suction Unit Model 78 00 20 is a portable, powered aspiration device designed for manual or automated suctioning of bodily fluids. Classified as a pump under FDA nomenclature, it is intended for clinical use in general and plastic surgery settings to clear airways or cavities of secretions, blood, or other fluids during medical procedures or patient care.
This device is supplied as a reusable medical instrument, requiring cleaning and sterilisation between uses. It is authorised under the FDA 510(k) pathway and the Medical Devices Directive (MDD), with a classification as a Class II device. The unit operates in various clinical environments and must be stored according to manufacturer guidelines to maintain functionality and sterility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK993668 | Date20 Dec 1999 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BTA
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Laerdal Medical A/S
Questions
Is the Laerdal Suction Unit Model 78 00 20 designed for single-use or can it be reused after proper cleaning and sterilization?
The Laerdal Suction Unit Model 78 00 20 is explicitly described as a reusable medical instrument. It requires cleaning and sterilization between uses to ensure safety and functionality, as stated in the manufacturer’s guidelines.
What clinical settings is this suction unit authorized for use in, and how does that relate to its intended purpose?
The device is authorized for use in general and plastic surgery settings, where it is intended to clear airways or cavities of secretions, blood, or other fluids during medical procedures or patient care. The advisory committee classification (General, Plastic Surgery) reflects its intended clinical applications, but it does not define its purpose—only the context in which it is used.
How should this suction unit be stored to maintain its functionality and sterility between uses?
The manufacturer provides storage guidelines to ensure the device remains functional and sterile. While the exact storage conditions aren’t detailed in the provided data, reusable medical devices like this typically require protection from contamination, moisture, and physical damage. Always follow the manufacturer’s instructions to avoid compromising performance or sterility.
What regulatory pathways does this suction unit follow, and what does that mean for its use in clinical environments?
The Laerdal Suction Unit Model 78 00 20 is authorized under the FDA 510(k) pathway and the Medical Devices Directive (MDD), with a classification as a Class II device. This means it has undergone regulatory review to demonstrate safety and effectiveness for its intended use in clinical settings, including general and plastic surgery, but does not imply any specific clinical indication beyond what is stated in the description.