510(k) · Cleared
ClearedEI Downpak Barrier Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hu-Friedy Mfg. Co., Inc. · EKM Gutta-Percha
Cleared on Feb 27, 2008 after an 89-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Feb 27, 2008
- Review
- 89 days
- Class
- Class I
- Product code
- EKM
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 EKM? 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? (1)
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 | K983406 | FDA’s K983406 is Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
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.
How does its category compare?
All EKM devicesEKM Gutta-Percha: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EKM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · EKM
Too few EKM 510(k)s in any year since 2007 to give a median.
Recalls per year · EKM
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EKM
6in 2025
MAUDE reports naming product code EKM, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 1 | 8 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This product is intended for use by dental professionals only. This device is an
accessory to the El DownPak Endodontic Obturator Handpiece which is used in the
oral cavity for root canal therapy. The barrier sleeve will be used to cover the hand
piece thereby reducing the risk of cross infection while in use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073369: EI Downpak Barrier Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073369
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026