# K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Aug 28, 2002 after 356 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
No predicates in its family tree.
83 later devices descend from it; 5 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) APTIMAX Instrument Tray for use in the STERRAD Sterilization System: named in the summary without a submission number
- (no number) STERRAD Instrument Tray: named in the summary without a submission number
- (no number) Instrument Management System: named in the summary without a submission number

## Most influential descendants
- K040223: Polyvac Instrument Delivery System (2004), 46 descendants of its own
- K131455: Restore Modular Sterilization Tray System (2013), 30 descendants of its own
- K120947: THS Instrument Tray (2012), 30 descendants of its own
- K152241: Medtronic Transportation/Sterilization Cassettes (2016), 29 descendants of its own
- K103213: Finess Endoscope Sterilization Tray (2011), 22 descendants of its own

## Indications for use
The APTIMAX Instrument Trays and accessories are designed to encase surgical instruments for sterilization. The APTIMAX Instrument Trays and accessories were previously indicated for use only with the Sterrad Sterilization Systems. This Premarket Notification expands the Indications for Use for the APTIMAX Instrument Trays and accessories to also include their use in prevacuum steam and ethylene oxide sterilization cycles.

Source page: https://510kreport.com/device/K013003
Methodology: https://510kreport.com/methodology