# K153025: Turbett Surgical Container

- Pathway: 510(k) (Traditional)
- Applicant: Turbett Surgical, LLC
- Decided: Jan 14, 2016 after 90 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K110898 (2012). 1 ancestor in all.
3 later devices descend 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)
- K110898: S.C.O.R.E.S. Unit, Ammed Surgical Equipment, LLC (2012) Summary page 6.

## Most influential descendants
- K200240: Turbett Instrument Pod (2020), 2 descendants of its own
- K202593: Turbett Instrument Pod (2021), 1 descendant of its own
- K250011: Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (2025), 0 descendants of its own

## Recalls of this device
- Dec 5, 2022 · Class II · Z-1038-2023: 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: 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: Devices were subject to unapproved rework processes.
- Apr 1, 2022 · Class II · Z-1111-2022: Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

## Indications for use
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.

Source page: https://510kreport.com/device/K153025
Methodology: https://510kreport.com/methodology