FDA product code HOD: Clamp, Eyelid, Ophthalmic

HOD is the FDA product code for clamp, eyelid, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HOD, from 3 different applicants. The average 510(k) review took 108 days (median 77).

Classification

FieldValue
Device nameClamp, Eyelid, Ophthalmic
Device classClass I
Regulation21 CFR 886.4350
Review panelOP — Ophthalmic
Medical specialtyOphthalmic
Premarket route510(k) exempt

Compare with all 510(k) review times · Search every HOD clearance

Top HOD applicants

ApplicantClearancesLatest
R.H. Burton Co.11993-04-14
Keeler Instruments, Inc.11989-06-05
Richard R. Anthony, M.D.11983-06-03

Most recent HOD clearances

510(k)ApplicantDeviceDecision dateReview days
K924774R.H. Burton Co.BURTON AUTOMATIC PROJECTOR - MODEL CP-401993-04-14203
K891610Keeler Instruments, Inc.HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER1989-06-0577
K831285Richard R. Anthony, M.D.SURGICAL/LID MARGIN COVER & EYELASH-1983-06-0344

Recalls for HOD devices

openFDA lists no recalls for product code HOD.

Frequently asked questions

What is FDA product code HOD?

HOD is the FDA product code for clamp, eyelid, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.

What device class is HOD?

Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code HOD?

Across 3 cleared submissions the average was 108 days from receipt to decision (median 77).

Which companies have the most HOD clearances?

R.H. Burton Co. (1); Keeler Instruments, Inc. (1); Richard R. Anthony, M.D. (1).

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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