510(k) · Cleared
ClearedOmni Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 26, 2019 as substantially equivalent to K121280 (Hologic, Inc., 2013) after a 210-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Feb 26, 2019
- Review
- 210 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K844002 (1984). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 1 generation backK121280 Myosure Intrument TrayHologic, Inc. · 2013
- This deviceK182052 Omni Instrument TrayHologic, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −1 | K121280 | Myosure Intrument Tray | Hologic, Inc. | 2013 | — |
| 0 (this device) | K182052 | Omni Instrument Tray | Hologic, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K121280 | Myosure Intrument TraySummary page 4…ication: Class II Panel: General Hospital PREDICATE DEVICE Tradename: MyoSure Instrument Tray Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K121280 Product Code: KCT Regulation: 21CFR 880.6850 DEVICE DESCRIPTION The Omni Instrument Tray is intended to enclo… | 2013 |
| † | K171692 | Instrument basket, for EndoEYE | 2018 |
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?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 6.0 years on median.
- None of the 10 ancestors has a 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. 2019, 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 Omni Instrument Tray is intended to enclose, protect, and organize The Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. The Omni Instrument Tray has been validated for the following sterilization cycles: Pre-vacuum Steam 132°C (270°F) 4 minutes exposure 35 minutes dry…
Read the full statement (157 words)
The Omni Instrument Tray is intended to enclose, protect, and organize The Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage.
The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles.
The Omni Instrument Tray has been validated for the following sterilization cycles:
Pre-vacuum Steam
132°C (270°F)
4 minutes exposure
35 minutes dry time
Contents:
- 1 Omni Hysteroscope
-1 Removable Outflow Channel
-1 XL Removable Outflow Channel
-1 Omni 3.7mm Diagnostic Sheath
-1 Omni 5.5mm Operative Sheath
- 1 Omni 6mm Operative Sheath
- 3 Seal Caps
- 2 Light Guide Adapters
STERRAD®
STERRAD NX™ Standard
STERRAD 100NX™ Standard
STERRAD 100S Short
Contents:
- 1 Omni Hysteroscope
-1 Removable Outflow Channel
-1 XL Removable Outflow Channel
-1 Omni 3.7mm Diagnostic Sheath
-1 Omni 5.5mm Operative Sheath
- 1 Omni 6mm Operative Sheath
- 3 Seal Caps
- 2 Light Guide Adapters
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/K182052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182052: Omni Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182052
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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