510(k) · Cleared
ClearedSmartsponge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearcount Medical Solutions, Inc. · LWH Counter, Sponge, Surgical
Cleared on May 24, 2007 as substantially equivalent to K060076 (Surgicount Medical, 2006) and 1 other predicate after a 9-day review. 4 later devices descend from it.
- Decided
- May 24, 2007
- Review
- 9 days
- Class
- Class I
- Product code
- LWH
- Recalls
- None
- Predicates
- 2
2 ancestors in all, the oldest K060076 (2006). 4 later devices descend from it, 2 citing it directly.
- This deviceK071355 Smartsponge SystemClearcount Medical Solutions, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK073180 Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK093557 Smartwand-DTXClearcount Medical Solutions · 2009
- Descendant · 3 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 · 2 generations on1descendant
- K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012 · 3 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 |
|---|---|---|---|---|---|
| 0 (this device) | K071355 | Smartsponge System | Clearcount Medical Solutions, Inc. | 2007 | — |
| +1 | K073180 | Smartsponge Plus System | Clearcount Medical Solutions, Inc. | 2007 | — |
| +2 | K093557 | Smartwand-DTX | Clearcount Medical Solutions | 2009 | — |
| +3 | K113021 | Trufreeze System, Trufreeze Spray Kit | CSA Medical, Inc. | 2012 | — |
| +1 | K100551 | Orlocate System Model Orl 100 | Haldor Advanced Technologies, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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…fied, 21 CER 880.2740, LWH Predicate Devices: Dukal Corporation X-ray detectable surgical sponges SurgiCount Medical, Inc. Safety-Sponge System, K060076 Digital Angel Corporation VeriChip implantable radio frequency transponder system, K0… | 2006 |
| * | DEN040007 | Implantable Radio Frequency Transponder System Our reading of the summary gave K033440, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040007, Implantable Radio Frequency Transponder System (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | |
| * | — | Dukal Corporation X-ray detectable surgical sponges Named without a submission number |
What descends from it? (4)
2 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. 2007, 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 ClearCount Medical Solutions SmartSponge TM System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparotomy sponges, and surgical towels used during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071355: Smartsponge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071355
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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