510(k) · Cleared
ClearedConmed Linvatec Instrument Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · FRG Wrap, Sterilization
Cleared on Oct 16, 2006 as substantially equivalent to K993535 (Riley Medical, Inc., 2001) and 2 other predicates after a 356-day review. Its family tree reaches back 5 generations to 1984. 42 later devices descend from it.
- Decided
- Oct 16, 2006
- Review
- 356 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K844002 (1984). 8 ancestors in all. 42 later devices descend from it, 2 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 backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- This deviceK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- Descendant · cites it directly · 30 of its ownK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- Descendant · 2 generations on · 20 of its ownK160730 Instrument kitsAnthogyr · 2017
- Descendant · 3 generations on · 18 of its ownK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- Descendant · 4 generations on · 13 of its ownK182865 Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- Descendant · cites it directly · 10 of its ownK070769 VHP 136 TraySTERIS Corporation · 2007
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015 · cites it directly30descendants
- K160730Instrument kitsAnthogyr · 2017 · 2 generations on20descendants
- K171713Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018 · 3 generations on18descendants
- K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019 · 4 generations on13descendants
- K070769VHP 136 TraySTERIS Corporation · 2007 · cites it directly10descendants
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 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| 0 (this device) | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| +1 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| +2 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| +3 | K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| +4 | K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| +1 | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 FRG? 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 FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K993535 | Metapak Multi-Purpose Instrument TraySummary page 2…FRG Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 2 of 4 D. Predicate/Legally Marketed Devices K993535 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. K023658 - Sterilization cases, trays and cassettes - Carr Medical P… | 2001 |
| * | K023658 | Sterilization Cases and TraysSummary page 2…trument Sterilization Tray 510(k) # K052992 Page 2 of 4 D. Predicate/Legally Marketed Devices K993535 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. K023658 - Sterilization cases, trays and cassettes - Carr Medical Products K944025 - MetaPak Multi-Purpose Instrument Tray - Riley Medica… | 2003 |
| * | K944025 | Surgical Instrument TraySummary page 2…egally Marketed Devices K993535 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. K023658 - Sterilization cases, trays and cassettes - Carr Medical Products K944025 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. E. Device Description The ConMed Linvatec sterilization trays… | 1994 |
What descends from it? (42)
See all 422 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 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, K142519 (Implant Direct Sybron Manufacturing, LLC, 2015) has gone furthest, with 30 descendants of its own.
- 7 other devices also cite its predicate K993535.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, 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 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses. The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization. The validated sterilization cycles are provided in Table II. The cycles were validated using Kimguard (Kimberly Clark). The sterilization exposure times are extended. Please refer to…
Read the full statement (129 words)
The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses.
The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization.
The validated sterilization cycles are provided in Table II.
The cycles were validated using Kimguard (Kimberly Clark).
The sterilization exposure times are extended. Please refer to Table 2 for cycle tines.
Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays.
The sterilized contents are for immediate use and should not be stored for any duration.
The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.
Table 1lists the trays included in this submission.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052992 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052992: Conmed Linvatec Instrument Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052992
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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