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

Shield, Nipple

21 CFR 880.5630 / General Hospital
FDA source (opens on fda.gov)

HFS is the FDA product code for Shield, Nipple, a class I device type, regulated under 21 CFR 880.5630. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HFS
Device name
Shield, Nipple
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
1

Clearances, product code HFS

By decision year
12 clearances under product code HFS with a decision year between 1981 and 1994, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HFS by decision year
YearClearances
19811
19831
19841
19851
19862
19932
19944

Applicants with the most clearances

Product code HFS
Applicants holding the most 510(k) clearances under product code HFS
ApplicantClearances
Marshall Baby Products2
Medela AG2
Avent America, Inc.1
Mali, Inc.1
Neonatal Corp.1
O'Donnell, Byrne & Williams1
Prolac, Inc.1
Reliance Products Corp.1
Sherwood Medical Co.1
Unicare Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order