510(k) · Cleared
ClearedDevon Sponge Counter Bags
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Industries, Inc. · LWH Counter, Sponge, Surgical
Cleared on Aug 26, 1991 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 26, 1991
- Review
- 61 days
- Class
- Class I
- Product code
- LWH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK912824 Devon Sponge Counter BagsDevon Industries, Inc. · 1991
- Descendant · cites it directly · 0 of its ownK120473 Pixel AppGauss Surgical, Inc., · 2012
Most influential descendants
Showing 1 of 1 · See all- K120473Pixel AppGauss Surgical, Inc., · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912824 | Devon Sponge Counter Bags | Devon Industries, Inc. | 1991 | — |
| +1 | K120473 | Pixel App | Gauss Surgical, Inc., | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120473 | Pixel App | 2012 | 0 |
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?
- Of its descendants, K120473 (Gauss Surgical, Inc.,, 2012) has gone furthest, with 0 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 | — |
https://510kreport.com/device/K912824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912824: Devon Sponge Counter Bags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912824
Report an extraction error
Are you the manufacturer?
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