Written and maintained by CASRAI Editorial Board
Last updated
General product information only, not medical advice. This page does not cover how to use a basin on a patient.
Short answer
An emesis basin is a shallow, usually kidney-shaped container used to collect the body wastes of a bed patient. The U.S. Food and Drug Administration lists it as “Basin, Emesis” (product code FNY) under the regulation for a body waste receptacle, 21 CFR 880.6730: a Class I device that is exempt from premarket notification (510(k)).
Definition and scope
FDA’s product classification database names the device “Basin, Emesis”, assigns it product code FNY, and files it under the General Hospital medical specialty. The regulation it falls under, 21 CFR 880.6730, Body waste receptacle, defines that category as “a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.”
Two points follow directly from that wording. The device is not attached to the body, which separates it from drainage and collection devices that connect to a patient. And the regulation describes the category by purpose (collecting body wastes), not by shape, so the shape and material of a given basin are product choices, not regulatory requirements.
Emesis basin and kidney dish
The kidney-shaped bowl is widely called a kidney dish in British usage and an emesis basin in American usage; Wikipedia’s “Kidney dish” article describes the two names as referring to the same type of item, though that article carries a citations-needed notice and is a secondary source. FDA’s own listing uses “Basin, Emesis” only. Product pages and supply catalogues may use either name, so search for both.
How FDA classifies an emesis basin
| Item | What the FDA record says |
|---|---|
| Device name | Basin, Emesis |
| Product code | FNY |
| Regulation number | 880.6730 (Body waste receptacle) |
| Device class | Class I (general controls) |
| Medical specialty | General Hospital |
| Premarket notification | Exempt, subject to the limitations in 21 CFR 880.9 |
| Quality management system requirements | Exempt, except for requirements concerning records and complaint files (21 CFR 820.35) |
| Summary malfunction reporting | Eligible |
Sources: FDA product classification database entry for FNY (via the openFDA classification endpoint, data last updated 2026-10-19) and the eCFR text of 21 CFR 880.6730, both checked on 2026-10-30. The regulation was last amended on 4 December 2025 (90 FR 55988); the current text refers to Part 820 as the quality management system regulation.
Class I means general controls only. General controls are the baseline requirements that apply to medical devices; the class system itself comes from the Medical Device Amendments of 1976. Exemption from premarket notification means a manufacturer does not need to file a 510(k) for this device type, within the limits of section 880.9. It does not mean the device is unregulated: the records and complaint-file requirements still apply, and device problems can still be reported under medical device reporting rules.
Reusable and single-use basins: what a listing should state
The regulation does not say a basin must be reusable, disposable, sterile or made from a particular material, so those facts have to come from the manufacturer’s own product information. These are the questions a product listing should be able to answer before a basin goes onto a supply list:
- Is it intended for single use or reuse? The regulation is silent on this; the manufacturer’s labelling decides. A reusable item brings a cleaning or reprocessing question that a single-use item does not.
- Is it labelled or represented as sterile? The quality management exemption in the FDA classification record is conditioned on the item not being labelled or represented as sterile. A basin sold as sterile is treated differently from a non-sterile one.
- What material is it? Not specified by the regulation, so confirm it from the product page or instructions.
- Does it state a capacity or dimensions? Sizes vary by product. Use the marked capacity on the listing, not an assumed one.
- Who is the manufacturer, and where are the product’s instructions or labelling? Because the device is 510(k)-exempt, there may be no 510(k) summary to read; the manufacturer’s labelling is the main product document.
Our palliative care unit supply checklist, endoscopy center supply checklist and concussion clinic supply checklist show how basins appear alongside other items on setting-specific supply lists.
Common misunderstandings
“It is a sterile medical device.”
Not by default. The classification record treats sterile labelling as an exception to the exemption, which implies the ordinary basin is not sterile unless its label says so.
“Class I means no rules apply.”
Class I means general controls. The device is exempt from premarket notification, but the records and complaint-file requirements remain.
“It is attached to the patient like a drainage device.”
No. The regulation’s definition is of a device that is “not attached to the body.”
“The regulation sets its size, shape or material.”
It does not. Those details come from each manufacturer’s product information.
FAQ
What is an emesis basin used for?
FDA’s regulation places it among devices used to collect the body wastes of a bed patient and not attached to the body. Instructions for using one on a patient belong to the manufacturer’s labelling and to clinical training, not to this page.
Is an emesis basin the same as a kidney dish?
The names refer to the same type of kidney-shaped bowl in common usage (emesis basin in the U.S., kidney dish in the UK, per a secondary source). FDA’s classification entry uses “Basin, Emesis”.
Is an emesis basin a regulated medical device?
Yes. FDA classifies it as Class I under 21 CFR 880.6730, exempt from 510(k) premarket notification.
Does an emesis basin have to be sterile?
The regulation does not require it. Whether a particular basin is sterile depends on how the manufacturer labels and represents it.
Sources
- U.S. Food and Drug Administration, Product Classification, product code FNY (Basin, Emesis), checked 2026-10-30.
- Electronic Code of Federal Regulations, 21 CFR 880.6730, Body waste receptacle, checked 2026-10-30 (text mirrored at Cornell LII).
- openFDA device classification API, product code FNY, data last updated 2026-10-19, checked 2026-10-30.
- Wikipedia, Kidney dish, secondary source used only for the naming note, checked 2026-10-30.
