# K250011: Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

- Pathway: 510(k) (Traditional)
- Applicant: Turbett Surgical
- Decided: Apr 4, 2025 after 92 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K110898 (2012). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202593: Turbett Instrument Pod, Turbett Surgical, Inc. (2021) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250011
Methodology: https://510kreport.com/methodology