510(k) · Cleared
ClearedTurbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turbett Surgical · FRG Wrap, Sterilization
Cleared on Apr 4, 2025 as substantially equivalent to K202593 (Turbett Surgical, Inc., 2021) after a 92-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Apr 4, 2025
- Review
- 92 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K110898 (2012). No later device cites it as a predicate yet.
- Root · 4 generations backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
- 3 generations backK153025 Turbett Surgical ContainerTurbett Surgical, LLC · 2016 · Recalled
- 2 generations backK200240 Turbett Instrument PodTurbett Surgical, Inc. · 2020
- 1 generation backK202593 Turbett Instrument PodTurbett Surgical, Inc. · 2021
- This deviceK250011 Turbett Surgical Instrument Pod (TS1500); Turbett Surgical…Turbett Surgical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | 1 |
| −3 | K153025 | Turbett Surgical Container | Turbett Surgical, LLC | 2016 | 4 |
| −2 | K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2020 | — |
| −1 | K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2021 | — |
| 0 (this device) | K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod… | Turbett Surgical | 2025 | — |
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 |
|---|---|---|---|
| * | K202593 | Turbett Instrument PodSummary page 5…880.6850 / FRG Primary Predicate Device: Turbett Surgical Instrument Pod, K202593 Submission Reason: Indications expansion Device Description The Turbett Su… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Instrument Pod 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 a pre-vacuum steam sterilizers with a pre-vacuum…
Read the full statement (230 words)
The Turbett Surgical Instrument Pod 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 a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes.
*The TS1500 Container may be loaded to a maximum weight of 375 Ibs., not to exceed 25 Ibs. in any tray. Minimum drying time for loads up to 140lbs. is 10minutes, for loads up to 375 Ibs. is 30 minutes.
*The TS1200 Container may be loaded to a maximum weight of 300 Ibs., not to exceed 25 1bs. in any tray. Minimum drying time is 10 minutes for loads up to120 Ibs. and 30 minutes for loads up to 300 Ibs.
*The TS1000 Container may be loaded to a maximum weight of 100 Ibs., not to exceed 25 1bs. in any tray. Minimum drying time is 10 minutes.
*The system was validated with 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens.
Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.
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/K250011 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250011: Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250011
Report an extraction error
Are you the manufacturer?
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