510(k) · Cleared
ClearedMD 420/440/460/470/480/490
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isopure, Corp. · FIP Subsystem, Water Purification
Cleared on Jan 24, 2000 as substantially equivalent to K944385 (International Purification Systems, Inc., 1995) after a 122-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Jan 24, 2000
- Review
- 122 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944385 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944385 MD400 a/B/C/D/E/F/GInternational Purification Systems, Inc. · 1995
- This deviceK993200 MD 420/440/460/470/480/490Isopure, Corp. · 2000
- Descendant · cites it directly · 3 of its ownK051620 Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd…Better Water, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK151637 UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015
- Descendant · 3 generations on · 0 of its ownK250514 UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK161844 Matrix Pre-Treatment ControllerBetter Water, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K051620Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd SeriesBetter Water, Inc. · 2005 · cites it directly3descendants
- K151637UPT Series Medical RO Water SystemSpecialty Water Technologies · 2015 · 2 generations on1descendant
- K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025 · 3 generations on0descendants
- K161844Matrix Pre-Treatment ControllerBetter Water, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944385 | MD400 a/B/C/D/E/F/G | International Purification Systems, Inc. | 1995 | — |
| 0 (this device) | K993200 | MD 420/440/460/470/480/490 | Isopure, Corp. | 2000 | — |
| +1 | K051620 | Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series | Better Water, Inc. | 2005 | — |
| +2 | K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015 | — |
| +3 | K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025 | — |
| +2 | K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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 14.1 · 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 |
|---|---|---|---|
| * | K944385 | MD400 a/B/C/D/E/F/GSummary page 3…SECTION 1: DEVICE MODIFICATION DESCRIPTION 1.1 Intended Use: As was tru¢ for the original registered HDA0OA--F Reverse Osmosis (RO) Machine device (510(k) application #K944385), the intended use of the modified RO machine device, i.e., the MD420-490 series, is inténded to purify water for Hemodialysis wh… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051620 | Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series | 2005 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K051620 (Better Water, Inc., 2005) has gone furthest, with 3 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 MD 420-490 series reverse osmosis system is intended to purify water for
hemodialysis when used as a component of a complete water purification system.
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/K993200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993200: MD 420/440/460/470/480/490.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993200
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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