HOWClass I

Drum, Opticokinetic

21 CFR 886.1200 / Ophthalmic

HOW is the FDA product code for Drum, Opticokinetic, a class I device type, regulated under 21 CFR 886.1200. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1982-11-01, and no recalls.

Classification record

Product code: HOW
Device name: Drum, Opticokinetic
Regulation: 21 CFR 886.1200
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code HOW

By decision year

1 clearance under product code HOW with a decision year between 1982 and 1982, 1982 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HOW by decision year
Year	Clearances
1982	1

Applicants with the most clearances

Product code HOW

Applicants holding the most 510(k) clearances under product code HOW
Applicant	Clearances
Life-Tech Intl., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code HOW

K822917Class IModel 5400 Optokinetic StimulatorLife-Tech Intl., Inc. / cleared 1982-11-01

Recent recalls

Product code HOW

FDA records show no recalls under product code HOW.

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)