510(k) Report

FDA product code · Ophthalmic

Chair, Ophthalmic, Manual

HMDClass I21 CFR 886.1140510(k) exempt1 decision since 19840 recalls

FDA lists HMD as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1984. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of HMD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · HMD

FDA has decided no HMD device since 2007.

Median 510(k) review, days · HMD

Too few HMD 510(k)s in any year since 2007 to give a median.

Recalls per year · HMD

No recall names HMD since 2007.

Adverse event reports per year · HMD

1in 2025

2017: 12020: 12025: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code HMD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — HMD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HMD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in HMD lately?

  • K833538Dowing Ophthalmic Chair-Non/AC PowerVision Health Technology · 1984

The one HMD decision →

Related product codes

Other codes under 21 CFR 886.1140.

HME Chair, Ophthalmic, Ac-Powered