510(k) · Cleared
ClearedSpecialty Sponges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultracell Medical Technologies, Inc. · GDY Gauze/Sponge, Internal, X-Ray Detectable
Cleared on Aug 6, 1992 after a 192-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 6, 1992
- Review
- 192 days
- Class
- Class I
- Product code
- GDY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK920355 Specialty SpongesUltracell Medical Technologies, Inc. · 1992
- Descendant · cites it directly · 0 of its ownK960621 Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996
Most influential descendants
Showing 1 of 1 · See all- K960621Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920355 | Specialty Sponges | Ultracell Medical Technologies, Inc. | 1992 | — |
| +1 | K960621 | Expandacell Instrument Wipe | Shippert Medical Technologies Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 GDY? 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 |
|---|---|---|---|
| K960621 | Expandacell Instrument Wipe | 1996 | 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, K960621 (Shippert Medical Technologies Corp., 1996) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GDY devicesGDY Gauze/Sponge, Internal, X-Ray Detectable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDY
FDA has decided no GDY device since 2007.
Median 510(k) review, days · GDY
Too few GDY 510(k)s in any year since 2007 to give a median.
Recalls per year · GDY
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GDY
112in 2025
MAUDE reports naming product code GDY, 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 | 15 |
| 2008 | 0 | — | 1 | 25 |
| 2009 | 0 | — | 0 | 96 |
| 2010 | 0 | — | 7 | 44 |
| 2011 | 0 | — | 0 | 38 |
| 2012 | 0 | — | 2 | 80 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 65 |
| 2015 | 0 | — | 2 | 122 |
| 2016 | 0 | — | 0 | 291 |
| 2017 | 0 | — | 1 | 252 |
| 2018 | 0 | — | 1 | 250 |
| 2019 | 0 | — | 1 | 177 |
| 2020 | 0 | — | 0 | 116 |
| 2021 | 0 | — | 0 | 134 |
| 2022 | 0 | — | 1 | 226 |
| 2023 | 0 | — | 0 | 98 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 112 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K920355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920355: Specialty Sponges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920355
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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