510(k) · Cleared
ClearedExpandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shippert Medical Technologies Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 9, 1996 as substantially equivalent to K791736 (Xomed, Inc., 1979) after a 39-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Dec 9, 1996
- Review
- 39 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791736 (1979). No later device cites it as a predicate yet.
- Root · 1 generation backK791736 Merocel Instrument WipeXomed, Inc. · 1979
- This deviceK964334 Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)Shippert 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) | K964334 | Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without) | Shippert Medical Technologies Corp. | 1996 | — |
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 GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K923843 | FDA’s K923843 is Fogless Our OCR of the scanned summary read K923843, FDA’s number for Fogless (Sorex Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “Anti-Fog Instrument Wipe”. Kept off the family tree. Summary page 1…7.92 SAFETY AND EFFECTIVENESS OF DEC 9 1996 EXPANDACELL™ ANTI-FOG INSTRUMENT WIPE The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that estab… | 1994 |
| * | K791736 | Merocel Instrument WipeSummary page 1…ND EFFECTIVENESS OF DEC 9 1996 EXPANDACELL™ ANTI-FOG INSTRUMENT WIPE The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this pr… | 1979 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K791736.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
https://510kreport.com/device/K964334 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964334: Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964334
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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