510(k) · Cleared
Recalled · Class II · 2022Turbett Surgical Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turbett Surgical, LLC · FRG Wrap, Sterilization
Cleared on Jan 14, 2016 as substantially equivalent to K110898 (Ammed Surgical Equipment, LLC, 2012) after a 90-day review. Its family tree reaches back 1 generation to 2012. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 14, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- FRG
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110898 (2012). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
- This deviceK153025 Turbett Surgical ContainerTurbett Surgical, LLC · 2016
- Descendant · cites it directly · 2 of its ownK200240 Turbett Instrument PodTurbett Surgical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK202593 Turbett Instrument PodTurbett Surgical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK250011 Turbett Surgical Instrument Pod (TS1500); Turbett Surgical…Turbett Surgical · 2025
Most influential descendants
Showing 3 of 3 · See all- K200240Turbett Instrument PodTurbett Surgical, Inc. · 2020 · cites it directly2descendants
- K202593Turbett Instrument PodTurbett Surgical, Inc. · 2021 · 2 generations on1descendant
- K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…Turbett Surgical · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | 1 |
| 0 (this device) | K153025 | Turbett Surgical Container | Turbett Surgical, LLC | 2016 | — |
| +1 | K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2020 | — |
| +2 | K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2021 | — |
| +3 | K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod… | Turbett Surgical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K110898 | S.C.O.R.E.S. UnitSummary page 6…n factors usability study Substantial Equivalence: The Turbett Surgical Container is substantially equivalent to the SCORES Unit Sterilization Container (K110898). Both products have the same indications for use and perform in a similar manner.… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200240 | Turbett Instrument Pod | 2020 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2022 | Class II | Z-1038-2023 | Device Design | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| Dec 5, 2022 | Class II | Z-1037-2023 | Device Design | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| Apr 14, 2022 | Class II | Z-1501-2022 | Process control | Devices were subject to unapproved rework processes. |
| Apr 1, 2022 | Class II | Z-1111-2022 | Device Design | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. |
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. 2016, this device’s year, is highlighted.
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 Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of…
Read the full statement (160 words)
The Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical filters.
The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray.
Validation was done using three trays per level and a maximum instrument load of 25 Ibs. per tray. The validation load included six Imm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
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/K153025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153025: Turbett Surgical Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153025
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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