510(k) · Cleared
Recalled · Class II · 2022Crosstex Non-Woven Sponges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crosstex Intl. · EFQ Gauze/Sponge, Internal
Cleared on Feb 18, 1999 as substantially equivalent to K821501 (Pro-Pak, 1982) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1981. It has been recalled 2 times.
- Decided
- Feb 18, 1999
- Review
- 87 days
- Class
- Class U
- Product code
- EFQ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K812736 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK812736 Softcare Barrier Wet DressingThe Kendal Co. · 1981
- This deviceK984187 Crosstex Non-Woven SpongesCrosstex Intl. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812736 | Softcare Barrier Wet Dressing | The Kendal Co. | 1981 | — |
| 0 (this device) | K984187 | Crosstex Non-Woven Sponges | Crosstex Intl. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 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 EFQ? 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 |
|---|---|---|---|
| * | K821501 | Sterile Tracheostomy Care Kit | 1982 |
| * | K830473 | Nova GauzeSummary page 1…ed: November 19, 1998 Crosstex Non-Woven Sponges a) Nu Gauze General Use Sponges, Johnson & Johnson, K#8211501 b) The Nova Gauze External Sponge, American Threshold, K#830473 c) Versalon, Kendall, K#812736 4. Device Description: The Crosstex Non-Woven Sponges consist of non-woven materials quarter f… | 1983 |
| * | K812736 | Softcare Barrier Wet DressingSummary page 1…on-Woven Sponges a) Nu Gauze General Use Sponges, Johnson & Johnson, K#8211501 b) The Nova Gauze External Sponge, American Threshold, K#830473 c) Versalon, Kendall, K#812736 4. Device Description: The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into: ® 2 X 2" (light) 4-… | 1981 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2022 | Class II | Z-1119-2022 | Other | Product not approved for release for US distribution |
| Mar 22, 2022 | Class II | Z-1118-2022 | Other | Product not approved for release for US distribution |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All EFQ devicesEFQ Gauze/Sponge, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFQ
FDA has decided no EFQ device since 2007.
Median 510(k) review, days · EFQ
Too few EFQ 510(k)s in any year since 2007 to give a median.
Recalls per year · EFQ
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFQ
51in 2025
MAUDE reports naming product code EFQ, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 53 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 1 | 8 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984187 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984187: Crosstex Non-Woven Sponges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984187
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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