510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HRDClass II

Sterilizer, Soft-Lens, Thermal, Ac-Powered

21 CFR 886.5928 / Ophthalmic
FDA source (opens on fda.gov)

HRD is the FDA product code for Sterilizer, Soft-Lens, Thermal, Ac-Powered, a class II device type, regulated under 21 CFR 886.5928. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HRD
Device name
Sterilizer, Soft-Lens, Thermal, Ac-Powered
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code HRD

By decision year
1 clearance under product code HRD with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HRD by decision year
YearClearances
19821

Applicants with the most clearances

Product code HRD
Applicants holding the most 510(k) clearances under product code HRD
ApplicantClearances
Safeway Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HRD.