510(k) · Cleared
ClearedConmed Detachatip Instrument Tray, 33CM and 43CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 10, 2010 as substantially equivalent to K032119 (Paragon Medical, Inc., 2003) after a 215-day review. Its family tree reaches back 5 generations to 1984. 1 later device descends from it.
- Decided
- Mar 10, 2010
- Review
- 215 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K844002 (1984). 8 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 backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- This deviceK092414 Conmed Detachatip Instrument Tray, 33CM and 43CMConmed Corporation · 2010
- Descendant · cites it directly · 0 of its ownK123175 Detachatip Iii Plus Instrument Tray Model 3-4343Conmed Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K123175Detachatip Iii Plus Instrument Tray Model 3-4343Conmed Corporation · 2013 · 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 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| 0 (this device) | K092414 | Conmed Detachatip Instrument Tray, 33CM and 43CM | Conmed Corporation | 2010 | — |
| +1 | K123175 | Detachatip Iii Plus Instrument Tray Model 3-4343 | Conmed Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K032119 | Paragon Medical Surgical Instrument Delivery System VariousSummary page 2…spital D. Predicate Device Paragon Medical Surgical Instrument Delivery Tray Paragon Medical 510O(K) # K032119 E. Intended Use The ConMedTM DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. Co… | 2003 |
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 |
|---|---|---|---|
| K123175 | Detachatip Iii Plus Instrument Tray Model 3-4343 | 2013 | 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 26 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K123175 (Conmed Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032119.
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. 2010, 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 ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed™ DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport DetachaTip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents. The 33cm DetachaTip Instrument Tray…
Read the full statement (263 words)
The ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed™ DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport DetachaTip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.
The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip Multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
2-1003 Metzenbaum, 33cm length
2-1005 5mm Babcock Grasper, 33cm length
2-1008 Fenestrated Grasper, 33cm length
2-1009 Curved Dissector, 33cm length
1-1010 Standard Handle
2-1013 Hook, 33cm length
2-1014 10mm Babcock, 33cm length
1-1015 Compact Handle
2-1017 Right Angle Meeker dissector 33cm
2-1018 Tapered Dissector, 33cm length
2-1019 Allis Grasper, 33cm length
1-1024 In-line Handle
1-1028 Endoweave Grasper, 33 cm length
The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with ConMed's 43cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
2-4301 Metzenbaum, 43cm length
2-4305 5mm Babcock Grasper, 43cm
2-4308 Curved Dissector, 43cm length
2-4307 Fenestrated Grasper, 43cm length
2-4314 10mm Babcock, 43cm
2-4317 Right Angle Meeker dissector 43cm
2-4318 Tapered Dissector, 43cm
2-4319 Allis Grasper, 43cm
2-4328 Endoweave Grasper, 43cm
Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:
Steam (wrapped), Pre-vacuum, 270°F (132°C), 4 minutes exposure time, 20 minutes dry cycle time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092414: Conmed Detachatip Instrument Tray, 33CM and 43CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092414
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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