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

Bronchoscope Accessory

21 CFR 874.4680 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KTI is the FDA product code for Bronchoscope Accessory, a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
KTI
Device name
Bronchoscope Accessory
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
34
Ingested recalls
12

Clearances, product code KTI

By decision year
34 clearances under product code KTI with a decision year between 1978 and 2026, 2025 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KTI by decision year
YearClearances
19781
19841
20022
20081
20091
20111
20152
20163
20173
20181
20191
20201
20211
20223
20234
20255
20263

Applicants with the most clearances

Product code KTI
Applicants holding the most 510(k) clearances under product code KTI
ApplicantClearances
Olympus Surgical Technologies America4
Boston Scientific Corporation3
Olympus Medical Systems Corp.3
Acclarent Inc2
Merit Medical Systems, Inc.2
Serpex Medical, Inc.2
Alton Shanghai Medical Instruments Co Ltd1
American Endoscopy, Inc.1
Asthmatx, Inc.1
Bryan Medical Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order