510(k) · Cleared

Cleared

Hygeniclear WKR 1, Water-Delivery Device Ultraclear

K990479510(k) TraditionalCleared May 13, 199986-day reviewClass I21 CFR 872.6640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hygenitek, Inc. · EIA Unit, Operative Dental

Cleared on May 13, 1999 as substantially equivalent to K971278 (Pure Co., 1997) and 4 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1988.

Decided: May 13, 1999
Review: 86 days
Class: Class I
Product code: EIA
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K882491 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK882491 Cutting Fluid System for Dental High Speed DrillsSteri-Sol, Inc. · 1988
This deviceK990479 Hygeniclear WKR 1, Water-Delivery Device UltraclearHygenitek, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882491	Cutting Fluid System for Dental High Speed Drills	Steri-Sol, Inc.	1988	—
0 (this device)	K990479	Hygeniclear WKR 1, Water-Delivery Device Ultraclear	Hygenitek, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1998	1	0

FIG. 1 — Lineage of K990479, 1988–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K971278	Pure Company Fluid Delivery System Summary page 1 …ribed in CFR 872.6640. VII. Substantial Equivalence: Hygeniclear™ WKR 1 is substantially equivalent to other devices cleared for marketing by the 510(k) process under K-971278 (Pure Company), K-971727 (DCI Water Purifier), K-964271 (IGN Waterline Unit), and K-882491, K-973765 (Micryllum Labs). The "510(…	Pure Co.	1997	—
*	K971727	Dci Water Purifier Summary page 1 …II. Substantial Equivalence: Hygeniclear™ WKR 1 is substantially equivalent to other devices cleared for marketing by the 510(k) process under K-971278 (Pure Company), K-971727 (DCI Water Purifier), K-964271 (IGN Waterline Unit), and K-882491, K-973765 (Micryllum Labs). The "510(k) "Substantial Equivalen…	Dental Components, Inc.	1997	—
*	K964271	Ign 500 TM Water Cleaning Unit with Calbenium Liquid Summary page 1 …geniclear™ WKR 1 is substantially equivalent to other devices cleared for marketing by the 510(k) process under K-971278 (Pure Company), K-971727 (DCI Water Purifier), K-964271 (IGN Waterline Unit), and K-882491, K-973765 (Micryllum Labs). The "510(k) "Substantial Equivalence" Decision-Making Process (De…	Airel-West	1997	—
*	K882491	Cutting Fluid System for Dental High Speed Drills Summary page 1 …quivalent to other devices cleared for marketing by the 510(k) process under K-971278 (Pure Company), K-971727 (DCI Water Purifier), K-964271 (IGN Waterline Unit), and K-882491, K-973765 (Micryllum Labs). The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandu…	Steri-Sol, Inc.	1988	—
*	K973765	BIO-2000 Summary page 1 …to other devices cleared for marketing by the 510(k) process under K-971278 (Pure Company), K-971727 (DCI Water Purifier), K-964271 (IGN Waterline Unit), and K-882491, K-973765 (Micryllum Labs). The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 wa…	Micrylium Laboratories	1998	—

Also cleared against K971278: 1 other device →

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 5 ancestors has a recall.
1 other device also cites its predicate K971278.

How does its category compare?

All EIA devices

EIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIA

7in 2025

2007high 7 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIA

178in 2025

2007high 686 (2023) · low 72 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EIA

1in 2013

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EIA

47in 2025

2007high 452 (2015) · low 0 (2007)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?

To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to improve the quality of water supplied to dental handpieces and other dental instruments.

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/K990479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990479: Hygeniclear WKR 1, Water-Delivery Device Ultraclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990479

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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