510(k) · Cleared
ClearedInstrument Cassette (EFCCL1-F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osung Mnd Co., Ltd. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 29, 2015 as substantially equivalent to K101653 (Miltex, Inc., 2010) after a 477-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Oct 29, 2015
- Review
- 477 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101653 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK101653 Miltex Thompson Cassettes; Miltex Surgical CassettesMiltex, Inc. · 2010
- This deviceK141854 Instrument Cassette (EFCCL1-F)Osung Mnd Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101653 | Miltex Thompson Cassettes; Miltex Surgical Cassettes | Miltex, Inc. | 2010 | — |
| 0 (this device) | K141854 | Instrument Cassette (EFCCL1-F) | Osung Mnd Co., Ltd. | 2015 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101653 | Miltex Thompson Cassettes; Miltex Surgical CassettesSummary page 4…21 CFR 880.6850 Class II KCT 4. Predicated Device Miltex Thompson Cassettes(K101653) Miltex Inc. 5. Device Description The OSUNG INSTRUMENT CASSETTE is designed to handle reusable dental instruments for ste… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
OSUNG INSTRUMENT CASSETTE (EFCCL1-F) is intended to hold instruments and accessories during
storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap
in order to maintain sterility.
This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility.
Validated sterilization parameters:
Cycle Type Temperature Exposure Time Dry Time
Gravity Steam 132℃ (270°F) 15 minutes 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141854: Instrument Cassette (EFCCL1-F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141854
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026