510(k) · Cleared
ClearedK5 Cart, K5 Mount, K5 Swing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Company., Ltd. Chair Business · EIA Unit, Operative Dental
Cleared on Jul 17, 2025 as substantially equivalent to K233805 (Osstem Implant Co., Ltd. Chair Business, 2024) after a 64-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 17, 2025
- Review
- 64 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962071 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 4 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 3 generations backK152830 K3Osstem Implant Co., Ltd. · 2017
- 2 generations backK183347 K3Osstem Implant Co., Ltd. · 2019
- 1 generation backK233805 K5Osstem Implant Co., Ltd. Chair Business · 2024
- This deviceK251491 K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −4 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −3 | K152830 | K3 | Osstem Implant Co., Ltd. | 2017 | — |
| −2 | K183347 | K3 | Osstem Implant Co., Ltd. | 2019 | — |
| −1 | K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | 2024 | — |
| 0 (this device) | K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 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 |
|---|---|---|---|
| * | K233805 | K5Summary page 5…21 CFR 872.6640 - Devce Classification : Class I - Classification Product Code : EIA, KLC 3. Predicated Device - K5(K233805) 4. Description The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use on… | 2024 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.
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/K251491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251491: K5 Cart, K5 Mount, K5 Swing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251491
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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