510(k) · Cleared
ClearedH20NLY Complete Water Purification System for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serv-A-Pure Co. · FIP Subsystem, Water Purification
Cleared on May 3, 2000 as substantially equivalent to K980182 (Usfilter/Ionpure, Inc., 1998) and 2 other predicates after a 198-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 3, 2000
- Review
- 198 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931595 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK931595 Reverse Osmosis Equipment for Water PurificationOsmonics, Inc. · 1994
- This deviceK993520 H20NLY Complete Water Purification System for HemodialysisServ-A-Pure Co. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931595 | Reverse Osmosis Equipment for Water Purification | Osmonics, Inc. | 1994 | — |
| 0 (this device) | K993520 | H20NLY Complete Water Purification System for Hemodialysis | Serv-A-Pure Co. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 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 FIP? 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 FIP device
- #1 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 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 |
|---|---|---|---|
| * | K980182 | Water Purification System for HemodialysisSummary page 1…nly Complete Water Purification System for Hemodialysis Claiming substantial equivalence to: U.S.Filter Company, (800) 466-7873 Water Treatment System for Hemodialysis K980182 Osmonics Inc., (612) 933-2277 Water Treatment System for Hemodialysis K931595 Better Water, (615) 355-6063 Water Treatment Syst… | 1998 |
| * | K931595 | Reverse Osmosis Equipment for Water PurificationSummary page 1…quivalence to: U.S.Filter Company, (800) 466-7873 Water Treatment System for Hemodialysis K980182 Osmonics Inc., (612) 933-2277 Water Treatment System for Hemodialysis K931595 Better Water, (615) 355-6063 Water Treatment System for Hemodialysis K920186 Intended Use: H20nly Water Purification System for… | 1994 |
| * | K920186 | Water Purification System for HemodialysisSummary page 1…Hemodialysis K980182 Osmonics Inc., (612) 933-2277 Water Treatment System for Hemodialysis K931595 Better Water, (615) 355-6063 Water Treatment System for Hemodialysis K920186 Intended Use: H20nly Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to… | 1995 |
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.
- 6 other devices also cite its predicate K980182.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, 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 | 1 | — | 0 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
H20nly Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
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/K993520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993520: H20NLY Complete Water Purification System for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993520
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