510(k) · Cleared
Recalled · Class II · 2022Surgicount Safety-Sponge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicount Medical · LWH Counter, Sponge, Surgical
Cleared on Mar 14, 2006 after a 63-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 14, 2006
- Review
- 63 days
- Class
- Class I
- Product code
- LWH
- Recalls
- 3
- Predicates
- 1
6 later devices descend from it, 3 citing it directly.
- This deviceK060076 Surgicount Safety-Sponge SystemSurgicount Medical · 2006
- Descendant · cites it directly · 4 of its ownK071355 Smartsponge SystemClearcount Medical Solutions, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK062642 RF Surgical Systems Inc. Detection System, Model 100ARf Surgical Systems, Inc. · 2006
- Descendant · 2 generations on · 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071355Smartsponge SystemClearcount Medical Solutions, Inc. · 2007 · cites it directly4descendants
- K062642RF Surgical Systems Inc. Detection System, Model 100ARf Surgical Systems, Inc. · 2006 · cites it directly4descendants
- K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007 · 2 generations on2descendants
- K093557Smartwand-DTXClearcount Medical Solutions · 2009 · 2 generations on1descendant
- K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060076 | Surgicount Safety-Sponge System | Surgicount Medical | 2006 | — |
| +1 | K071355 | Smartsponge System | Clearcount Medical Solutions, Inc. | 2007 | — |
| +1 | K062642 | RF Surgical Systems Inc. Detection System, Model 100A | Rf Surgical Systems, Inc. | 2006 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K960036 | FDA’s K960036 is Firard II/ TDP Lamp The summary prints BK960036, a CBER number, which our reading took as K960036, FDA’s number for Firard II/ TDP Lamp (Helio Medical Supplies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SMS Blood Bank Transfusion System”. Kept off the family tree. Summary page 1…co/Kendall X-ray detectable surgical sponges Tyco BAG-IT Sponge Counting System SMS Blood Bank Transfusion System, BK960036 Device Description: The Safety Sponges include surgical sponges, laparatomy pads and surgical to… | 1996 |
| * | — | Tyco/Kendall X-ray detectable surgical sponges Named without a submission number | |
| * | — | Tyco BAG-IT Sponge Counting System Named without a submission number |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2022 | Class II | Z-1452-2022 | Under Investigation by firm | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this… |
| Mar 21, 2016 | Class II | Z-1379-2016 | Software design | The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is… |
| Jun 16, 2013 | Class II | Z-0986-2015 | Device Design | Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071355 (Clearcount Medical Solutions, Inc., 2007) has gone furthest, with 4 descendants of its own.
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 SurgiCount Medical Safety-Sponge SystemTM is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060076: Surgicount Safety-Sponge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060076
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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