# K151594: Ellipse Supplemental Instrument Trays

- Pathway: 510(k) (Abbreviated)
- Applicant: Ellipse Technologies, Incorporated
- Decided: Jan 25, 2016 after 227 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844002 (1984). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071783: Versapod (TM) Instrument Trays, Containmed, Inc. (2008) Summary page 5.

## Most influential descendants
- K170939: Supplemental Instrument Trays (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K151594
Methodology: https://510kreport.com/methodology