510(k) · Cleared
ClearedModification to: Med-RO Reverse Osmosis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usfilter/Ionpure, Inc. · FIP Subsystem, Water Purification
Cleared on Mar 8, 2002 after a 121-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 8, 2002
- Review
- 121 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK013677 Modification to: Med-RO Reverse Osmosis SystemUsfilter/Ionpure, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK030652 Medro SPDUsfilter/Ionpure, Inc. · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K030652Medro SPDUsfilter/Ionpure, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013677 | Modification to: Med-RO Reverse Osmosis System | Usfilter/Ionpure, Inc. | 2002 | — |
| +1 | K030652 | Medro SPD | Usfilter/Ionpure, Inc. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | — | USFilter/Ionpure, Inc. M-Series Reverse Osmosis Water Purification System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030652 | Medro SPD | 2003 | 0 |
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, K030652 (Usfilter/Ionpure, Inc., 2003) has gone furthest, with 0 descendants of its own.
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?
The USFilter/Ionpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001[RD-5: 1992 if applicable]. The Med-RO™ Reverse Osmosis System is intended to be used in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.
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/K013677 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013677: Modification to: Med-RO Reverse Osmosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013677
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026