510(k) · Cleared
ClearedMerocel Instrument Wipe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · GEC Brush, Scrub, Operating-Room
Cleared on Sep 19, 1979 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 19, 1979
- Review
- 19 days
- Class
- Class I
- Product code
- GEC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK791736 Merocel Instrument WipeXomed, Inc. · 1979
- Descendant · cites it directly · 0 of its ownK964334 Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)Shippert Medical Technologies Corp. · 1996
- Descendant · cites it directly · 0 of its ownK960621 Expandacell Instrument WipeShippert Medical Technologies Corp. · 1996
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791736 | Merocel Instrument Wipe | Xomed, Inc. | 1979 | — |
| +1 | K964334 | Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without) | Shippert Medical Technologies Corp. | 1996 | — |
| +1 | K960621 | Expandacell Instrument Wipe | Shippert Medical Technologies Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964334 (Shippert Medical Technologies Corp., 1996) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K791736 · printed Nov 5, 2026
Cite this page
510(k) Report. “K791736: Merocel Instrument Wipe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K791736
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026