510(k) · Cleared
ClearedMyosure Intrument 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 8, 2013 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 1 other predicate after a 284-day review. Its family tree reaches back 5 generations to 1984. 1 later device descends from it.
- Decided
- Feb 8, 2013
- Review
- 284 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844002 (1984). 9 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 backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- This deviceK121280 Myosure Intrument TrayHologic, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK182052 Omni Instrument TrayHologic, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182052Omni Instrument TrayHologic, Inc. · 2019 · 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 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| 0 (this device) | K121280 | Myosure Intrument Tray | Hologic, Inc. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 1…T 10.3 Predicate Device: Trade Name: Polyvac Surgical Instrument Delivery System Submitter/S10(k) holder: Symmetry Medical, Inc. 510(k) Numbers: K012105 and K(040223 10.4 Device Description The MyoSure Instrument Tray consists of an approximate 13.45 inch x 8.41 inch x 2… | 2002 |
| * | K040223 | Polyvac Instrument Delivery SystemSummary page 1…dicate Device: Trade Name: Polyvac Surgical Instrument Delivery System Submitter/S10(k) holder: Symmetry Medical, Inc. 510(k) Numbers: K012105 and K(040223 10.4 Device Description The MyoSure Instrument Tray consists of an approximate 13.45 inch x 8.41 inch x 2.0 inch… | 2004 |
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 |
|---|---|---|---|
| K182052 | Omni Instrument Tray | 2019 | 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 29 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K182052 (Hologic, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K012105.
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. 2013, 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 MyoSure Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions. The MyoSure…
Read the full statement (115 words)
The MyoSure Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions.
The MyoSure Instrument Tray has been validated for the following sterilization cycles:
Prevacuum Steam: 132°C (270°F), 4 minutes exposure, 30 minutes dry time
Gravity Steam: 132°C (270°F), 15 minutes exposure, 30 minutes dry time
STERRAD 100S: 59% H₂O₂, Normal Cycle Setting
Contents: 1 MyoSure Rod Lens Hysteroscope and accessories
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121280: Myosure Intrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121280
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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