510(k) · Cleared
ClearedPure Company Fluid Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pure Co. · EIA Unit, Operative Dental
Cleared on Jul 3, 1997 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 87 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971278 | Pure Company Fluid Delivery System | Pure Co. | 1997 | — |
| +1 | K990479 | Hygeniclear WKR 1, Water-Delivery Device Ultraclear | Hygenitek, Inc. | 1999 | — |
| +1 | K981171 | Eradic-All | Theratechnologies, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K990479 (Hygenitek, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air. The operation of the the Fluid Delivery System is facilitated by a rotary…
Read the full statement (139 words)
The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.
The operation of the the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature.
The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971278: Pure Company Fluid Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971278
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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