HMQClass I

Marker, Sclera

21 CFR 886.4570 / Ophthalmic

HMQ is the FDA product code for Marker, Sclera, a class I device type, regulated under 21 CFR 886.4570. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: HMQ
Device name: Marker, Sclera
Regulation: 21 CFR 886.4570
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
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 55 companies shown, in name order

Recent clearances

Product code HMQ

FDA records hold no clearances under product code HMQ.

Recent recalls

Product code HMQ

Z-1256-2026Class IIThere may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised...Vortex Surgical Inc. / initiated 2025-12-16 / 14,789 (8651 US; 6138 OUS)

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)