510(k) · Cleared
ClearedRF Surgical Systems Inc. Detection System, Model 100A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rf Surgical Systems, Inc. · LWH Counter, Sponge, Surgical
Cleared on Nov 2, 2006 as substantially equivalent to K060076 (Surgicount Medical, 2006) after a 57-day review. Its family tree reaches back 1 generation to 2006. 4 later devices descend from it.
- Decided
- Nov 2, 2006
- Review
- 57 days
- Class
- Class I
- Product code
- LWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060076 (2006). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK060076 Surgicount Safety-Sponge SystemSurgicount Medical · 2006 · Recalled
- This deviceK062642 RF Surgical Systems Inc. Detection System, Model 100ARf Surgical Systems, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK073180 Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK093557 Smartwand-DTXClearcount Medical Solutions · 2009
- Descendant · 2 generations on · 0 of its ownK113021 Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK100551 Orlocate System Model Orl 100Haldor Advanced Technologies, Ltd. · 2010
Most influential descendants
Showing 4 of 4 · See all- K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007 · cites it directly2descendants
- K093557Smartwand-DTXClearcount Medical Solutions · 2009 · cites it directly1descendant
- K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012 · 2 generations on0descendants
- K100551Orlocate System Model Orl 100Haldor Advanced Technologies, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060076 | Surgicount Safety-Sponge System | Surgicount Medical | 2006 | 3 |
| 0 (this device) | K062642 | RF Surgical Systems Inc. Detection System, Model 100A | Rf Surgical Systems, Inc. | 2006 | — |
| +1 | K073180 | Smartsponge Plus System | Clearcount Medical Solutions, Inc. | 2007 | — |
| +1 | K093557 | Smartwand-DTX | Clearcount Medical Solutions | 2009 | — |
| +2 | K113021 | Trufreeze System, Trufreeze Spray Kit | CSA Medical, Inc. | 2012 | — |
| +1 | K100551 | Orlocate System Model Orl 100 | Haldor Advanced Technologies, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K060076 | Surgicount Safety-Sponge SystemSummary page 1…Surgical Sponge Counter Classification Name: Surgical Sponge Counter, unclassified, 21 CFR 888.2740 Predicate Devices: SurgiCount Medical, Safety Sponge Tm K060076 TycolKendall X-ray Detectable Sponges (Various) 510(k) Exempt Tyco Bag-IT Sponge Co… | 2006 |
| * | — | Tyco/Kendall X-ray Detectable Sponges (Various) Named without a submission number | |
| * | — | Tyco Bag-IT Sponge Counting System Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LWH devicesLWH Counter, Sponge, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 RF Surgical Systems Inc. Detection System is intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062642: RF Surgical Systems Inc. Detection System, Model 100A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062642
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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