510(k) · Cleared
ClearedTurbett Instrument Pod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turbett Surgical, Inc. · FRG Wrap, Sterilization
Cleared on Apr 30, 2020 as substantially equivalent to K153025 (Turbett Surgical, LLC, 2016) after a 90-day review. Its family tree reaches back 2 generations to 2012. 2 later devices descend from it.
- Decided
- Apr 30, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K110898 (2012). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
- 1 generation backK153025 Turbett Surgical ContainerTurbett Surgical, LLC · 2016 · Recalled
- This deviceK200240 Turbett Instrument PodTurbett Surgical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK202593 Turbett Instrument PodTurbett Surgical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK250011 Turbett Surgical Instrument Pod (TS1500); Turbett Surgical…Turbett Surgical · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | 1 |
| −1 | K153025 | Turbett Surgical Container | Turbett Surgical, LLC | 2016 | 4 |
| 0 (this device) | K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2020 | — |
| +1 | K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K153025 | Turbett Surgical ContainerSummary page 4…Class II (21 CFR 880.6850) 4. Common/Classification Sterilization wrap/container; Name: 5. Predicate Device: Turbett Surgical Container K153025 Description: The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a sing… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202593 | Turbett Instrument Pod | 2021 | 1 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K202593 (Turbett Surgical, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132°C)…
Read the full statement (228 words)
The Turbett 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. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.
The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132°C) and exposure time of 4 minutes.
• The TS1500 Container may be loaded to a maximum weight of 375 lbs., not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes.
• The TS1200 Container may be loaded to a maximum weight of 120 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
• The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
• The system was validated with 1mm x 500mm lumens. Do not use with instruments containing lumens with an inner diameter of smaller than 1mm and an overall length longer that 500mm.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200240: Turbett Instrument Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200240
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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