IDYClass I

Bath, Flotation, Tissue

21 CFR 864.3010 / Pathology

IDY is the FDA product code for Bath, Flotation, Tissue, a class I device type, regulated under 21 CFR 864.3010. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: IDY
Device name: Bath, Flotation, Tissue
Regulation: 21 CFR 864.3010
Device class: Class I
Review panel: Pathology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order

Recent clearances

Product code IDY

FDA records hold no clearances under product code IDY.

Recent recalls

Product code IDY

Z-0287-2013Class IIDako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the...Dako North America Inc. / initiated 2008-05-01 / 136 units

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)