510(k) · Cleared
ClearedTuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuttnauer U.S.A Co, Ltd. · FRG Wrap, Sterilization
Cleared on Jul 9, 1999 as substantially equivalent to K944025 (Riley Medical, Inc., 1994) and 1 other predicate after a 123-day review. Its family tree reaches back 2 generations to 1984. 1 of the 155 devices in its family, counting itself, has a Class I recall. 150 later devices descend from it.
- Decided
- Jul 9, 1999
- Review
- 123 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K844002 (1984). 4 ancestors in all. 150 later devices descend from it, 2 citing it directly. 1 of the 155 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 1 generation backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- This deviceK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- Descendant · cites it directly · 149 of its ownK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- Descendant · 2 generations on · 58 of its ownK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- Descendant · 2 generations on · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- Descendant · 2 generations on · 43 of its ownK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- Descendant · 3 generations on · 42 of its ownK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
Showing 5 of 150 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K050220 Evis Exera Bronchovideoscope, Olympus…3 generations on · 2005
Most influential descendants
Showing 5 of 150 · See all- K012105Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002 · cites it directly149descendants
- K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004 · 2 generations on58descendants
- K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · 2 generations on46descendants
- K023658Sterilization Cases and TraysCarr Metal Products, Inc. · 2003 · 2 generations on43descendants
- K052992Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −1 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| 0 (this device) | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| +1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| +2 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| +2 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| +2 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| +3 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 1 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 15 | 0 |
| 2020 | 10 | 0 |
| 2021 | 19 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K944025 | Surgical Instrument TraySummary page 1…tially equivalent to the following currently marketed sterilization cassettes: Company Product Name 510(k) Clearance Number Riley Medical, Inc. Surgical Instrument Tray K944025 Plastic Sterilizing Tray Corp. PST Trays Unknown C/T Med-Systems Ltd., Inc C/T Med-Systems Cassette System K980065 General Desc… | 1994 |
| * | K980065 | C/T Med-Systems Cassette SystemSummary page 1…e Number Riley Medical, Inc. Surgical Instrument Tray K944025 Plastic Sterilizing Tray Corp. PST Trays Unknown C/T Med-Systems Ltd., Inc C/T Med-Systems Cassette System K980065 General Description: The Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette are sterilization cassettes tha… | 1998 |
| * | — | PST Trays Named without a submission number |
What descends from it? (150)
See all 1502 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 3 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K012105 (Symmetry Medical, Inc., 2002) has gone furthest, with 149 descendants of its own.
- 3 other devices also cite its predicate K944025.
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 Tuttnauer Mini Container and Standard Case Cassettes are general dental/medical instrument cassettes intended to hold instruments and accessories in place during the sterilization cycle. The devices are indicated for use in both gravity and pre-vacuum steam sterilization.
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/K990761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990761: Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990761
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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