Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NHV — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
209 daysmedian FDA review time
273 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (2 | I3 Membrane GmbH | 2023-06-02 | 267 | 0 |
| K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | 2019-10-25 | 134 | 0 |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filte | Ecolab, Inc. | 2019-03-29 | 231 | 0 |
| K173164 | Ecolab POU Water Filter | Ecolab, Inc. | 2018-06-29 | 273 | 0 |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water | Pall International Sarl | 2017-06-01 | 161 | 0 |
| K161467 | HydraGuard 10 UltraFilter | Nephros, Inc. | 2016-12-22 | 209 | 0 |
| K153784 | NOSOGARD FILTERS | Evoqua Water Technologies, LLC | 2016-10-21 | 295 | 0 |
| K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016-06-10 | 196 | 0 |
| K153084 | Nephros S100 | Nephros, Inc. | 2016-04-08 | 165 | 0 |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | Nephros, Inc. | 2014-10-24 | 119 | 0 |
| K012716 | MAINSTREAM WATER PURIFICATION DEVICE | Prismedical Corp. | 2002-05-07 | 265 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda