510(k) · Cleared
ClearedExpandacell Instrument Wipe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shippert Medical Technologies Corp. · GEC Brush, Scrub, Operating-Room
Cleared on Apr 1, 1996 as substantially equivalent to K920355 (Ultracell Medical Technologies, Inc., 1992) and 2 other predicates after a 48-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Apr 1, 1996
- Review
- 48 days
- Class
- Class I
- Product code
- GEC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K791736 (1979). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK791736 Merocel Instrument WipeXomed, Inc. · 1979
- This deviceK960621 Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791736 | Merocel Instrument Wipe | Xomed, Inc. | 1979 | — |
| 0 (this device) | K960621 | Expandacell Instrument Wipe | Shippert Medical Technologies Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 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 GEC? 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 |
|---|---|---|---|
| * | K920355 | Specialty SpongesSummary page 5…ments of SMDA 1990 and 21 CFR 807.9 SAFETY AND EFFECTIVENESS OF EXPANDACELL ™ INSTRUMENT WIPE The Expandacell Instrument Wipe is identical to existing medical devices, K920355, K791736 and K891101. These Instrument Wipes, marketed by Ultracell, Xomed/Merocel and Smith and Nephew have 3 proven track recor… | 1992 |
| * | K791736 | Merocel Instrument WipeSummary page 5…SMDA 1990 and 21 CFR 807.9 SAFETY AND EFFECTIVENESS OF EXPANDACELL ™ INSTRUMENT WIPE The Expandacell Instrument Wipe is identical to existing medical devices, K920355, K791736 and K891101. These Instrument Wipes, marketed by Ultracell, Xomed/Merocel and Smith and Nephew have 3 proven track record that es… | 1979 |
| * | K891101 | Non-Absorbable Gauze, Surgical Sponge & DressingSummary page 5…d 21 CFR 807.9 SAFETY AND EFFECTIVENESS OF EXPANDACELL ™ INSTRUMENT WIPE The Expandacell Instrument Wipe is identical to existing medical devices, K920355, K791736 and K891101. These Instrument Wipes, marketed by Ultracell, Xomed/Merocel and Smith and Nephew have 3 proven track record that establishes th… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All GEC devicesGEC Brush, Scrub, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEC
FDA has decided no GEC device since 2007.
Median 510(k) review, days · GEC
Too few GEC 510(k)s in any year since 2007 to give a median.
Recalls per year · GEC
No recall names GEC since 2007.
Adverse event reports per year · GEC
3in 2024
MAUDE reports naming product code GEC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.
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/K960621 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960621: Expandacell Instrument Wipe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960621
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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