# K202593: Turbett Instrument Pod

- Pathway: 510(k) (Traditional)
- Applicant: Turbett Surgical, Inc.
- Decided: May 19, 2021 after 253 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: 3 generations back to K110898 (2012). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200240: Turbett Instrument Pod, Turbett Surgical, Inc. (2020) Summary page 4.

## Most influential descendants
- K250011: Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (2025), 0 descendants of its own

## Indications for use
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 until used. 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 (132C) 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 140 Ibs. is 10 minutes, for loads up to 375 lbs. 30 minutes. * The TS1200 Container may be loaded to a maximum weight of 120 Ibs., not to exceed 25 Ibs. in any tray. Minimum drying time is 10 minutes. * The TS1000 Container may be loaded to a maximum weight of 100 Ibs., not to exceed 25 Ibs. in any tray. Minimum drying time is 10 minutes. » The system was validated with Imm x 500mm lumens. Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.

Source page: https://510kreport.com/device/K202593
Methodology: https://510kreport.com/methodology