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

Perineometer

21 CFR 884.1425 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HIR is the FDA product code for Perineometer, a class II device type, regulated under 21 CFR 884.1425. As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HIR
Device name
Perineometer
Regulation
21 CFR 884.1425
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
No
Ingested clearances
65
Ingested recalls
1

Clearances, product code HIR

By decision year
65 clearances under product code HIR with a decision year between 1979 and 2026, 1995 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code HIR by decision year
YearClearances
19791
19802
19821
19865
19892
19911
19921
19942
19957
19962
19973
19982
20004
20012
20025
20091
20132
20143
20152
20161
20172
20181
20191
20202
20213
20221
20233
20242
20261

Applicants with the most clearances

Product code HIR
Applicants holding the most 510(k) clearances under product code HIR
ApplicantClearances
Pelvital USA, Inc.5
Hollister, Inc.4
Renovia, Inc.4
Thought Technology Ltd.3
Verimed Holdings, Inc.3
Advanced Tactile Imaging, Inc.2
Analytica, Ltd.2
Bioinfinity (M) Sdn. Bhd.2
Cardio Design Pty., Ltd.2
Deschutes Medical Products, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order