510(k) · Cleared
ClearedErgonomic Products Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ergonomic Products, Inc. · EIA Unit, Operative Dental
Cleared on Apr 18, 2014 as substantially equivalent to K000966 (A-Dec, Inc., 2000) and 2 other predicates after a 267-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 18, 2014
- Review
- 267 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K935325 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935325 A-Dec Cascade 3072 WallmountA-Dec, Inc. · 1994
- This deviceK132315 Ergonomic Products WorkstationErgonomic Products, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935325 | A-Dec Cascade 3072 Wallmount | A-Dec, Inc. | 1994 | — |
| 0 (this device) | K132315 | Ergonomic Products Workstation | Ergonomic Products, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 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? (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 |
|---|---|---|---|
| * | K000966 | 4631 Duo Delivery SystemSummary page 1…lations: 21 CFR 872.6640 Class: HI Product Code: EIA Review Panel: Dental D) Predicates: K000966 A-Dec 4631 Duo Delivery System, A-Dec, hic. K935325 A-Dec Cascade 3072 Wallmount, A-Dec, ic.… | 2000 |
| * | K935325 | A-Dec Cascade 3072 WallmountSummary page 1…: EIA Review Panel: Dental D) Predicates: K000966 A-Dec 4631 Duo Delivery System, A-Dec, hic. K935325 A-Dec Cascade 3072 Wallmount, A-Dec, ic. K962071 Spirit S 1/S2, Pelton & Crane, Co. E) Device Desc… | 1994 |
| * | K962071 | Spirit S1/S2Summary page 1…K000966 A-Dec 4631 Duo Delivery System, A-Dec, hic. K935325 A-Dec Cascade 3072 Wallmount, A-Dec, ic. K962071 Spirit S 1/S2, Pelton & Crane, Co. E) Device Description: The Ergonomic Products Workstations provide a consolidated work area… | 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 EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Ergonomic Products Workstation is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device is to be operated and used by dentists and other legally qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132315: Ergonomic Products Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132315
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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