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

Transducer, Pressure, Intrauterine

21 CFR 884.2700 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFN is the FDA product code for Transducer, Pressure, Intrauterine, a class II device type, regulated under 21 CFR 884.2700. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HFN
Device name
Transducer, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
1

Clearances, product code HFN

By decision year
9 clearances under product code HFN with a decision year between 1989 and 2025, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HFN by decision year
YearClearances
19892
19921
19963
19971
19981
20251

Applicants with the most clearances

Product code HFN
Applicants holding the most 510(k) clearances under product code HFN
ApplicantClearances
Clinical Innovations, LLC4
Telos Medical Corp.2
Utah Medical Products, Inc2
Laurel Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code