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

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

21 CFR 880.6850 / General Hospital
FDA source (opens on fda.gov)

KCT is the FDA product code for Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a class II device type, regulated under 21 CFR 880.6850. As of , FDA records hold 280 510(k) clearances under this code, the most recent dated , and 38 recalls.

Classification record

Product code
KCT
Device name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
282
Ingested recalls
38

Clearances, product code KCT

By decision year
282 clearances under product code KCT with a decision year between 1976 and 2026, 2019 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code KCT by decision year
YearClearances
19761
19774
19781
19793
19811
19821
19834
19841
19851
19861
19881
19895
19901
19921
19931
199413
19959
19962
19973
19983
19992
20021
20031
20045
20053
20062
20073
20086
20096
201012
20116
201210
20138
201411
201515
201612
201710
201815
201918
202014
202118
202211
202310
20248
202511
20267

Applicants with the most clearances

Product code KCT
Applicants holding the most 510(k) clearances under product code KCT
ApplicantClearances
Aesculap Inc13
STERIS Corporation11
JJGC Industria e Comercio de Materiais Dentarios SA10
Summit Medical, LLC8
Medtronic, Inc.7
Intuitive Surgical, Inc.7
Smith & Nephew, Inc.7
Case Medical, Inc.6
Dentsply Sirona Inc5
Miltex, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 259 companies shown, in name order