510(k) · Cleared
ClearedEllipse Supplemental Instrument Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellipse Technologies, Incorporated · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jan 25, 2016 as substantially equivalent to K071783 (Containmed, Inc., 2008) after a 227-day review. Its family tree reaches back 5 generations to 1984. 1 later device descends from it.
- Decided
- Jan 25, 2016
- Review
- 227 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K844002 (1984). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK071783 Versapod (TM) Instrument TraysContainmed, Inc. · 2008
- This deviceK151594 Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK170939 Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated · 2017
Most influential descendants
Showing 1 of 1 · See all- K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K071783 | Versapod (TM) Instrument Trays | Containmed, Inc. | 2008 | — |
| 0 (this device) | K151594 | Ellipse Supplemental Instrument Trays | Ellipse Technologies, Incorporated | 2016 | — |
| +1 | K170939 | Supplemental Instrument Trays | Nuvasive Specialized Orthopedics, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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 |
|---|---|---|---|
| * | K071783 | Versapod (TM) Instrument TraysSummary page 5…The Ellipse Supplemental Instrument Trays are substantially equivalent to the following 510(k) cleared device: ContainMed, Inc. VersaPod™ Instrument Trays (K071783) 7. Product Description: The Ellipse Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray and a S… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170939 | Supplemental Instrument Trays | 2017 | 0 |
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?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K170939 (Nuvasive Specialized Orthopedics, Incorporated, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071783.
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. 2016, 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?
The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle: Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time The worst case validated sterilization load is: -One (1)…
Read the full statement (271 words)
The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The worst case validated sterilization load is:
-One (1) Supplemental Instrument Tray with instruments (total weight: 10.0 Ibs.) and one (1) Supplemental Reamer Tray with instruments (total weight: 13.1 Ibs.): in a non-stacked configuration.
The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions:
Supplemental Instrument Tray (Model SIT1-000)
Instrument Model Description Dimension (Inner Diameter x Length) Number of Lumens
TCDI1-000 Teardrop Cannulated Driver 02107 x 4.58” |
CEDI-011 1 Imm Cannulated Entry Drill 0.146” x 10.75 1
GWCI1-000 Guide Wire Chuck 0.2507x5.07 |
LQC1-000 Large AO Quick Connect 0.175"x 291" |
DGA1-000 Direct AO Depth Gauge 03947 x 1043~ 1
The worst case loading configuration included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:
Supplemental Reamer Tray (Model SRT1-000):
Instrument Model Description Dimension (Inner Diameter x Length) Number of Lumens
RMRI-110 Flexible Reamer, 10.0mm 0.125"x 184 |
RMR1-135 Flexible Reamer, 13.5mm 0.1257x 18.4” |
RMR1-140 Flexible Reamer, 14.0mm 0.1257x 18.4” |
RMR1-145 Flexible Reamer, 14.5mm 0.1257x 18.4” |
RMRI-150 Flexible Reamer, 15.0mm 0.125"x 184 |
Do not exceed a maximum load of 12 instruments (10.0 1bs.) in the Supplemental Instrument Tray.
Do not exceed a maximum load of 18 instruments (13.1 1bs.) in the Supplemental Reamer Tray.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151594: Ellipse Supplemental Instrument Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151594
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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