# K100551: Orlocate System Model Orl 100

- Pathway: 510(k) (Traditional)
- Applicant: Haldor Advanced Technologies, Ltd.
- Decided: Aug 12, 2010 after 167 days
- Product code: LWH (Counter, Sponge, Surgical)
- Device class: 1
- Regulation: 21 CFR 880.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060076 (2006). 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)
- K071355: Smartsponge System, Clearcount Medical Solutions, Inc. (2007)
- K062642: RF Surgical Systems Inc. Detection System, Model 100A, Rf Surgical Systems, Inc. (2006) Summary page 1.
- K060076: Surgicount Safety-Sponge System, Surgicount Medical (2006) Summary page 1.

## Indications for use
The ORLocateTM System is indicated for use in recording and counting the number of REID-tagged surgical sponges, laparotomny sponges, towels and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained REID-tagged surgical sponges, towels and other tagged items within a surgical site, as an adjunctive detection method to current surgical counting systems and methods.

Source page: https://510kreport.com/device/K100551
Methodology: https://510kreport.com/methodology