Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KCT — Predicate Candidate Screening
280 FDA 510(k) clearances under this product code; the 50 most recent screened below.
151 daysmedian FDA review time
335 days90th percentile
280clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 | 265 | 0 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 | 90 | 0 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 | 268 | 0 |
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick C | DePuy Mitek, Inc. | 2026-02-26 | 90 | 0 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 | 255 | 0 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 | 158 | 0 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 | 85 | 0 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 | 260 | 0 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 | 212 | 0 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 | 243 | 0 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 | 115 | 0 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 | 270 | 0 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical | Prismatik Dentalcraft, Inc. | 2025-03-21 | 205 | 0 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 | 223 | 0 |
| K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 | 112 | 0 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 | 119 | 0 |
| K243128 | Klockner Kits | SOADCO, S.L. | 2024-12-18 | 79 | 0 |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 | 87 | 0 |
| K240898 | SteriTite rigid reusable sterilization container with MediTr | Case Medical | 2024-07-31 | 121 | 0 |
| K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | 2024-07-16 | 90 | 0 |
| K241378 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-12 | 58 | 0 |
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corporation | 2024-06-03 | 396 | 0 |
| K233578 | BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC | 2024-03-22 | 136 | 0 |
| K231144 | Washtrays | Dentsply Sirona | 2024-01-16 | 270 | 0 |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | 2023-12-22 | 84 | 0 |
| K233222 | Aygün Sterilization Container Systems | Aygun Surgical Instruments Co., Inc. | 2023-12-12 | 75 | 0 |
| K231604 | Instrument Case | Cochlear Americas | 2023-08-24 | 84 | 0 |
| K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | 2023-08-07 | 75 | 0 |
| K230680 | Anthogyr Surgical Cassettes | Anthogyr | 2023-07-11 | 120 | 0 |
| K230804 | Complement Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-07-07 | 106 | 0 |
| K231219 | NobelZygoma PureSet™ Tray | Nobel Biocare Services AG | 2023-06-27 | 60 | 0 |
| K222640 | Sweden & Martina Surgical Trays | Sweden & Martina S.P.A. | 2023-05-26 | 267 | 0 |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-04-20 | 135 | 0 |
| K223672 | Instrument Case P1340904 | Cochlear | 2023-03-21 | 104 | 0 |
| K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022-12-30 | 372 | 0 |
| K222514 | S.I.N. Instrument Kits | S.I.N. – Sistema DE Implante Nacional S.A. | 2022-10-27 | 69 | 0 |
| K221492 | SteriTite Container System with MediTray Parts | Case Medical, Inc. | 2022-10-07 | 137 | 0 |
| K222005 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-09-29 | 84 | 0 |
| K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Stericube, LLC | 2022-09-28 | 57 | 0 |
| K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022-05-03 | 46 | 0 |
| K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2022-04-29 | 246 | 0 |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2022-04-13 | 107 | 0 |
| K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022-03-04 | 226 | 0 |
| K210923 | Southern Implants Instrument Trays | Southern Implants (Pty), Ltd. | 2022-03-02 | 338 | 0 |
| K203177 | Sterisystem Dry-Base Instrument Tray | O&M Halyard, Inc. | 2022-01-02 | 433 | 0 |
| K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip | K1 Medical, LLC | 2021-12-28 | 90 | 0 |
| K203468 | TCAT TKA Instrument Tray | THINK Surgical, Inc. | 2021-12-20 | 390 | 0 |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III T | Nobel Biocare Services AG | 2021-12-18 | 94 | 0 |
| K210836 | InstruSafe Instrument Protection System | Summitt Medical, LLC | 2021-11-30 | 253 | 0 |
| K212068 | Biotech Dental Kits | Biotech Dental, Sas | 2021-11-08 | 129 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda