510(k) · Cleared
ClearedMetapak Multi-Purpose Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riley Medical, Inc. · FRG Wrap, Sterilization
Cleared on Dec 7, 2001 as substantially equivalent to K944025 (Riley Medical, Inc., 1994) after a 780-day review. Its family tree reaches back 1 generation to 1994. 130 later devices descend from it.
- Decided
- Dec 7, 2001
- Review
- 780 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944025 (1994). 130 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK944025 Surgical Instrument TrayRiley Medical, Inc. · 1994
- This deviceK993535 Metapak Multi-Purpose Instrument TrayRiley Medical, Inc. · 2001
- Descendant · cites it directly · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- Descendant · cites it directly · 42 of its ownK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- Descendant · 2 generations on · 30 of its ownK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- Descendant · 2 generations on · 30 of its ownK131455 Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013
- Descendant · 2 generations on · 30 of its ownK120947 THS Instrument TrayHologic, Inc. · 2012
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · cites it directly46descendants
- K052992Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006 · cites it directly42descendants
- K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015 · 2 generations on30descendants
- K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013 · 2 generations on30descendants
- K120947THS Instrument TrayHologic, Inc. · 2012 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944025 | Surgical Instrument Tray | Riley Medical, Inc. | 1994 | — |
| 0 (this device) | K993535 | Metapak Multi-Purpose Instrument Tray | Riley Medical, Inc. | 2001 | — |
| +1 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| +1 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| +2 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| +2 | K131455 | Restore Modular Sterilization Tray System | Restore Medical Solutions, Inc. | 2013 | — |
| +2 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 14 | 0 |
| 2020 | 10 | 0 |
| 2021 | 15 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K944025 | Surgical Instrument TraySummary page 2…re-vacuum steam and ethylene oxide sterilization processes, The MetaPak Instrument Tray is identical to the predicate MultiPak Instrument Tray, cleared for marketing a5 K944025, with the exception of a modification to the matetrials for the container base. The original MultiPak Instrument Tray container b… | 1994 |
| * | — | Sklar Instruments Instrument Tray Named without a submission number |
What descends from it? (130)
See all 1308 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040223 | Polyvac Instrument Delivery System | 2004 | 46 |
| K052992 | Conmed Linvatec Instrument Sterilization Tray | 2006 | 42 |
| K152241 | Medtronic Transportation/Sterilization Cassettes | 2016 | 29 |
| K032119 | Paragon Medical Surgical Instrument Delivery System Various | 2003 | 18 |
| K073551 | Smith & Nephew Instrument Trays | 2008 | 13 |
| K130532 | Idrive Ultra Sterilization Tray | 2013 | 6 |
| K102103 | Skeletal Dynamics Sterilization Trays | 2010 | 4 |
| K110500 | Stat-Mat Minor | 2011 | 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?
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 Riley Medical MetaPak Multi-Purpose Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.
The Riley Medical MetaPak Multi-Purpose Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
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/K993535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993535: Metapak Multi-Purpose Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993535
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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