510(k) · Cleared
ClearedExpandacell Injecto-Pak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shippert Medical Technologies Corp. · EMX Balloon, Epistaxis
Cleared on Aug 1, 1996 as substantially equivalent to K935724 (Denver Splint Co., 1994) and 2 other predicates after a 59-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 1, 1996
- Review
- 59 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K935724 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935724 The Expandacell Sinus PackDenver Splint Co. · 1994
- This deviceK962133 Expandacell Injecto-PakShippert Medical Technologies Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935724 | The Expandacell Sinus Pack | Denver Splint Co. | 1994 | — |
| 0 (this device) | K962133 | Expandacell Injecto-Pak | Shippert Medical Technologies Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 EMX? 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 EMX device
- #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K935724 | The Expandacell Sinus PackSummary page 1…d. This proposed change to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Expandacell Sinus Pack K935724/S1, Expandacell Injecto-Pak, K954845, and the Expandacell Injecto-Pak K960228 have a proven track record that establishes this pr… | 1994 |
| * | K954845 | Expandacell Injecto-Pak Nasal PackSummary page 1…y approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Expandacell Sinus Pack K935724/S1, Expandacell Injecto-Pak, K954845, and the Expandacell Injecto-Pak K960228 have a proven track record that establishes this product line as safe to the post-operat… | 1995 |
| * | K960228 | Expandacell Injecto-Pak Nasal PackSummary page 1…way alter the safety and effectiveness of this medical device. The Expandacell Sinus Pack K935724/S1, Expandacell Injecto-Pak, K954845, and the Expandacell Injecto-Pak K960228 have a proven track record that establishes this product line as safe to the post-operative nasal or post-operative sinus surgery… | 1996 |
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 EMX devicesEMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMX
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EMX
Too few EMX 510(k)s in any year since 2007 to give a median.
Recalls per year · EMX
No recall names EMX since 2007.
Adverse event reports per year · EMX
16in 2025
MAUDE reports naming product code EMX, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For administration of liquid medication and hydrating for the sinus.
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/K962133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962133: Expandacell Injecto-Pak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962133
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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