510(k) · Cleared
ClearedDental Barrier and Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fomed Industries, Inc. · PEM Dental Barriers And Sleeves
Cleared on Jun 10, 2025 as substantially equivalent to K190484 (Bh Medical Products Co., Ltd., 2019) after a 91-day review. Its family tree reaches back 3 generations to 2014.
- Decided
- Jun 10, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K132953 (2014). No later device cites it as a predicate yet.
- Root · 3 generations backK132953 TidisheildTidi Products,Llc · 2014
- 2 generations backK151123 Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc. · 2016
- 1 generation backK190484 BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019
- This deviceK250735 Dental Barrier and SleevesFomed Industries, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132953 | Tidisheild | Tidi Products,Llc | 2014 | — |
| −2 | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film | Pac-Dent International, Inc. | 2016 | — |
| −1 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019 | — |
| 0 (this device) | K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | 2025 | — |
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 PEM? 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 PEM device
- #1 K250606 Dental Barrier and Sleevesscore 13.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190484 | BH Medical Dental Barrier Sleeves and Barrier FilmSummary page 5…d Sleeves 878.4370 PEM | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K190484 BH Medical Dental Barrier Sleeves and Barrier Film PEM Device Description Summary 21 CFR 807.92(a)(4) Dental Barrier and Sle… | 2019 |
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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K190484.
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PEM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEM
163in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PEM
No recall names PEM since 2007.
Adverse event reports per year · PEM
No MAUDE report names PEM since 2007.
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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | 163 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
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/K250735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250735: Dental Barrier and Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250735
Report an extraction error
Are you the manufacturer?
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