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

Monitor, Esophageal Motility, Anorectal Motility, And Tube

21 CFR 876.1725 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KLA is the FDA product code for Monitor, Esophageal Motility, Anorectal Motility, And Tube, a class II device type, regulated under 21 CFR 876.1725. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KLA
Device name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
31
Ingested recalls
1

Clearances, product code KLA

By decision year
31 clearances under product code KLA with a decision year between 1977 and 2025, 1996 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KLA by decision year
YearClearances
19773
19821
19882
19891
19901
19911
19931
19941
19951
19964
19972
19991
20021
20032
20041
20071
20121
20151
20171
20181
20242
20251

Applicants with the most clearances

Product code KLA
Applicants holding the most 510(k) clearances under product code KLA
ApplicantClearances
Oakfield Instruments, Ltd.3
Mediplus Ltd.2
Medspira, LLC2
Physio Control, Inc.2
Diversatek Healthcare Inc2
Synectics-Dantec2
Thd SpA2
Wilson-Cook Medical Inc.2
Clinical Innovations, LLC1
Dentsleeve Pty., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order