510(k) · Cleared
ClearedOrlocate System Model Orl 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haldor Advanced Technologies, Ltd. · LWH Counter, Sponge, Surgical
Cleared on Aug 12, 2010 as substantially equivalent to K071355 (Clearcount Medical Solutions, Inc., 2007) and 2 other predicates after a 167-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Aug 12, 2010
- Review
- 167 days
- Class
- Class I
- Product code
- LWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K060076 (2006). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060076 | Surgicount Safety-Sponge System | Surgicount Medical | 2006 | 3 |
| −1 | K062642 | RF Surgical Systems Inc. Detection System, Model 100A | Rf Surgical Systems, Inc. | 2006 | — |
| 0 (this device) | K100551 | Orlocate System Model Orl 100 | Haldor Advanced Technologies, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071355 | Smartsponge System | 2007 |
| * | K062642 | RF Surgical Systems Inc. Detection System, Model 100ASummary page 1…ass 1, 21 CFR 878.4450, GDY Predicate Clearcount Medical SmartSponge K(07 1355 Devices: RE Surgical Systems Inc. detection system, K(062642 SurgiCou~nt Medical, Inc. Safety-Sponge System, K(060076 Device H-aldor ORLocateTM sys… | 2006 |
| * | K060076 | Surgicount Safety-Sponge SystemSummary page 1…t Medical SmartSponge K(07 1355 Devices: RE Surgical Systems Inc. detection system, K(062642 SurgiCou~nt Medical, Inc. Safety-Sponge System, K(060076 Device H-aldor ORLocateTM system is an REID system providing a solution Description: that enables the… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K071355.
How does its category compare?
All LWH devicesLWH Counter, Sponge, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LWH
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWH
Too few LWH 510(k)s in any year since 2007 to give a median.
Recalls per year · LWH
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWH
34in 2025
MAUDE reports naming product code LWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 1 | 5 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 40 |
| 2017 | 0 | — | 0 | 107 |
| 2018 | 0 | — | 0 | 64 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 0 | 41 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100551: Orlocate System Model Orl 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100551
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026